FDA Device Recalls

Recalls / Firms / Siemens Healthcare Diagnostics, Inc.

Siemens Healthcare Diagnostics, Inc.

720 FDA device recalls on record.

DateClassProductReason
2026-02-23—Atellica CH Enzymatic Hemoglobin A1c (A1c_E); Siemens Material Number (SMN): 11097536;
2026-01-20—Atellica CH Urine Albumin (UAlb). Material Number: 11537225
2025-10-06—3gAllergy Specific IgE Universal Kit; Kit Component: 3gAllergy Specific IgE Adjustor Antibody (L2UNS
2025-10-06—Food Panel 3 Specific Allergen; Siemens Material Number (SMN): 10385891; Catalog Number: FP3L4;
2025-10-06—IMMULITE 2000 Oak Mix Specific Allergen; Siemens Material Number (SMN): 10386105; Catalog Number: L2
2025-09-22—Assay: IMMULITE 2000 Intact PTH; Test Code: iPT; Siemens Material Number (SMN): (1) 10381441, (2) 10
2025-08-11—Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP). Material Number: 11097543.
2025-07-07—epoc BGEM BUN Test Card [25pk]. Material Number: 10736515.
2025-06-26—RAPIDPoint 500 Systems Wash/Waste Cartridge (4 Pack). Material Number: 10329097.
2025-06-04—ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN2 Control)
2025-06-04—ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (ABN1 Control)
2025-06-04—ADVIA 120/2120/2120i 3-in-1 TESTpoint Control (Norm Control)
2025-06-04—ADVIA 120/2120/2120i SETpoint Calibrator
2025-05-22—Product: Atellica CH Diluent - CONS 2 x 1.5L; Siemens Material Number (SMN): 11099300;
2025-04-15—Atellica IM Homocysteine Calibrator (2 Pack). Siemens Material Number: 10995498
2025-04-15—ADVIA Centaur HCY Calibrator (2 Pack). Siemens Material Number: 10310376.
2025-03-31—Stratus CS Acute Care cTNI TestPak.IVD test for cardiac troponin I in heparinized plasma.
2025-03-19—epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN): 1
2025-03-19—epoc BGEM Crea Test Card (25 pk) for the epoc Blood Analysis System; Siemens Material Number (SMN):
2025-03-11—Atellica CH Revised C Reactive Protein (RCRP); Siemens Material Number (SMN): 11537223.
2024-11-22—epoc NXS Host; Siemens Material Number (SMN): 11413879(IN) ; Software Version Number: 4.14.9. Int
2024-11-22—epoc NXS Host; Siemens Material Number (SMN): 11413497 (EU); Software Version Number: 4.14.9. Int
2024-11-22—epoc NXS Host; Siemens Material Number (SMN): 11413475 (US); Software Version Number: 4.14.9. Inten
2024-11-22—epoc NXS Host; Siemens Material Number (SMN): 11413506 (CA); Software Version Number: 4.14.9. Int
2024-11-22—epoc NXS Host; Siemens Material Number (SMN): 11413498(JP) ; Software Version Number: 4.14.9. Int
2024-11-22—epoc NXS Host; Siemens Material Number (SMN): 11413517(MX) ; Software Version Number: 4.14.9. Int
2024-11-22—epoc NXS Host; Siemens Material Number (SMN): 11413583(CN, KR) ; Software Version Number: 4.14.9.
2024-11-22—epoc NXS Host; Siemens Material Number (SMN): 11413518 (ROW) ; Software Version Number: 4.14.9. I
2024-11-12—Magnesium Flex reagent cartridge, 360 tests, Catalog Number: K3057; Siemens Material Number (SMN): 1
2024-11-04—Atellica CI Analyzer. Catalog Numbers: 10947347.
2024-10-21—Atellica CH 2-Microglobulin (B2M) - In vitro diagnostic use in the quantitative determination of 2-m
2024-10-21—Siemens Atellica CH Reaction Ring Cuvette Segment-has cuvettes that contain and incubate the sample
2024-09-30—IMMULITE 2000 PSA assay, Catalog Number L2KPTS2(D) (SMN 10706281) and Catalog Number L2KPTS6(D) (SMN
2024-09-24—epoc BGEM BUN Test Card (25 pk) for the epoc Blood Analysis System, SMN 10736515
2024-08-21—Atellica IM aTPO Assay, Material Number 10995466 (100 Test) and 10995467 (500 Test)
2024-08-21—ADVIA Centaur aTPO Assay, Material Number 10630886 (100 Test) and 10630887 (500 Test)
2024-08-15—ADVIA Chemistry Microalbumin_2 (ALB_2) -For in vitro diagnostic use in the quantitative measurement
2024-08-15—Atellica CH Microalbumin_2 (ALB_2)-For in vitro diagnostic use in the quantitative measurement of mi
2024-07-30—Dimension Vista Total Bilirubin (TBIL) Flex Reagent Cartridge; Siemens Material Number (SMN): 104451
2024-07-29—ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11319151
2024-07-29—Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP); Siemens Material Number (SMN): 11097543
2024-07-26—Atellica IM CA 19-9 (250 Test - REF)-In vitro diagnostic use in the quantitative measurement of the
2024-07-26—ADVIA Centaur CA 19-9 (250 Test)-In vitro diagnostic use in the quantitative measurement of the CA 1
2024-07-26—Atellica IM CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19-9
2024-07-26—Atellica IM CA 19-9 (250 Test)- In vitro diagnostic use in the quantitative measurement of the CA 19
2024-07-26—ADVIA Centaur CA 19-9 (50 Test)-In vitro diagnostic use in the quantitative measurement of the CA 19
2024-05-17—Software version 5.3 in: RAPIDPoint 500e Blood Gas System (USA) Siemens Material Number: 11416751
2024-04-23—IMMULITE 2000 Anti-TG Ab Catalog # L2KTG6 (600 Tests), SMN 10381655, System, Test, Thyroid Autoant
2024-04-23—IMMULITE 2000 Anti-TG Ab Catalog # L2KTG2 (200 Tests), SMN 10381659, System, Test, Thyroid Autoant
2024-03-13—Atellica CH Iron3 - IVD use in the quantitative measurement of iron in human serum and plasma (lithi
2024-02-07—DCA Systems HbA1c Reagent Kit
2024-01-24—Atellica IM Erythropoietin (EPO) Assay (100 Test)
2024-01-24—ADVIA Centaur Erythropoietin (EPO) Assay (100 Test)
2023-12-15—Total immunoglobulin M (IgM total) IVD, kit, nephelometry/turbidimetry
2023-10-26—RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 750-Intended for in vitro diagnostic use
2023-10-26—RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 400-Intended for in vitro diagnostic use
2023-10-26—RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 250-Intended for in vitro diagnostic use
2023-10-26—RAPIDPoint 500 Systems Measurement Cartridge (with Lactate) 100 -Intended for in vitro diagnostic u
2023-10-19—epoc NXS Host Blood Analysis System, Siemens Material Numbers 11413497 (EU), 11413475 (US), 11413506
2023-09-26—RAPIDPOINT 500 Blood Gas System
2023-09-26—RAPIDPOINT 500e Blood Gas System
2023-08-08—ADVIA Chemistry Iron_2 (IRON_2) Reagents, Material Numbers 10377510 (6 x 350 tests) and 10341118 (7
2023-07-25—ADVIA Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), Material Number 11319151, in vitro diag
2023-07-10—Atellica CH HDL Cholesterol- In vitro diagnostic use in the quantitative determination of HDL chole
2023-07-10—Atellica CH LDL Cholesterol- In vitro diagnostic use in the quantitative determination of LDL choles
2023-07-10—Atellica CH Gamma-Glutamyl Transferase-IIn vitro diagnostic use in the quantitative determination of
2023-07-10—Atellica CH Total Bilirubin_2 -In vitro diagnostic use in the quantitative determination of total bi
2023-06-01—epoc BGEM BUN Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
2023-06-01—epoc BGEM Test Card (BUN & TCO2),Veterinary with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor C
2023-06-01—epoc BGEM Crea Test Card with epoc Host SW v3.37.3, epoc NXS SW v4.10.6, Sensor Configuration 41.1
2023-05-16—Aptio Automation Storage and Retrieval Module (SRM)
2023-04-05—ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2
2023-04-05—Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica CH Toxicology Calibrator (TOX CAL) is for i
2023-03-16—Atellica IM Cortisol 50T (Material Number 10995538), 250T (Material Number 10995537), and REF 250T (
2023-03-16—ADVIA Centaur Cortisol 50T (Material Number 10994924), ADVIA Centaur Cortisol 250T (Material Number
2023-01-30—Dimension Tacrolimus (TAC) Flex reagent cartridge-In vitro diagnostic test for the quantitative meas
2023-01-27—Atellica CH Triglycerides_2: in vitro diagnostic use in the quantitative determination of triglyceri
2023-01-27—Atellica CH LDL Cholesterol Direct (DLDL)-In vitro diagnostic quantitative determination of LDL chol
2023-01-27—Atellica CH Triglycerides (concentrated)-In vitro diagnostic use in the quantitative measurement of
2023-01-27—Atellica CH Total Protein II- In vitro diagnostic use in the quantitative determination of total pro
2023-01-09—ADVIA Centaur Folate 500 test kit (REF)-For in vitro diagnostic use in the quantitative determinatio
2023-01-09—Atellica IM Folate 140 test kit- For in vitro diagnostic use in the quantitative determination of fo
2023-01-09—ADVIA Centaur Folate 500 test kit- For in vitro diagnostic use in the quantitative determination of
2023-01-09—Atellica IM Folate 700 test kit- For in vitro diagnostic use in the quantitative determination of fo
2023-01-09—ADVIA Centaur Folate 100 test kit-For in vitro diagnostic use in the quantitative determination of f
2023-01-09—Atellica IM Folate 700 test kit (REF)-For in vitro diagnostic use in the quantitative determination
2022-12-22—ADVIA Centaur XP and ADVIA Centaur XPT Anti-HBe2 (aHBe2) 50T- In vitro diagnostic immunoassay for th
2022-12-12—epoc Host 2 as follows: Product SMN epoc Host 10736387 epoc Host 2, Canada 1073638
2022-12-12—epoc Host 2 as follows: Product SMN epoc NXS Host, US 11413475 epoc NXS Host, EU
2022-12-07—IMMULITE 2000 Thyroglobulin (US)- For in vitro diagnostic use with the IMMULITE 2000 Systems Analyz
2022-12-07—IMMULITE 2000 Thyroglobulin (OUS). For in vitro diagnostic use with the IMMULITE 2000 Systems Analyz
2022-11-04—IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests Japan Siemens Material Number (SM
2022-11-04—IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests OUS, except Japan Siemens Materia
2022-11-04—IMMULITE 2000 Systems 3gAllergy Specific IgE Universal Kit Tests (600T)- US. Siemens Material Numbe
2022-10-25—IMMULITE and IMMULITE 1000 Total Testosterone Assay- In vitro diagnostic use with the IMMULITE and I
2022-09-19—Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11532401. in vitro diagnostic assay
2022-09-19—Atellica CH Lithium (Li), Siemens Material Number 11097535. in vitro diagnostic assay
2022-08-30—N Antiserum to Human IgG, 5mL Variant for BN II System and BN ProSpec System- IVD Siemens Materia
2022-08-30—N Antiserum to Human IgG, 2mL Variant for BN II System and BN ProSpec System-IVD Siemens Material Nu
2022-08-24—Dimension Vista High Density Lipoprotein Cholesterol (HDLC) Flex reagent cartridge, IVD Siemens Mate
2022-08-17—Dimension Magnesium (MG) Flex reagent cartridge Siemens Material Number (SMN)/REF (Catalog Number):1
2022-08-11—IMMULITE 2000 and IMMULITE 2000 XPi Thyroid Stimulating Immunoglobulins (TSI) Siemens Material Numbe
2022-07-18—Dimension Vista LOCI CA 15-3 Flex reagent cartridge. In Vitro Diagnostic for the quantitative measu
2022-06-28—Atellica CH Iron_2 (Iron_2) is for in vitro diagnostic use in the quantitative determination of iron
2022-06-01—epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of s
2022-05-18—Dimension CTNI-In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels i
2022-05-18—Dimension LTNI -In vitro diagnostic test intended to quantitively measure cardiac troponin-I levels
2022-04-13—Atellica IM 1300 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic
2022-04-13—Atellica IM 1600 Analyzer - automated, immunoassay analyzer designed to perform in vitro diagnostic
2022-03-03—Atellica IM Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determinatio
2022-03-03—Atellica IM Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative determ
2022-03-03—Atellica IM Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determinatio
2022-03-03—ADVIA Centaur Enhanced Estradiol (eE2) 500T - In vitro diagnostic use in the quantitative determinat
2022-03-03—ADVIA Centaur Enhanced Estradiol (eE2) (REF) 500T - In vitro diagnostic use in the quantitative dete
2022-03-03—ADVIA Centaur Enhanced Estradiol (eE2) 100T - In vitro diagnostic use in the quantitative determinat
2022-02-22—IMMULITE 2000 Systems HCG [200 Tests, material number 10381206, catalog number L2KCG] and [600 Tests
2022-02-09—Atellica CH Enzymatic Hemoglobin A1c (A1c_E/A1c_H), Siemens Material Number 11097536
2022-02-09—Atellica CH Lithium_2 (LITH_2), Siemens Material Number 11097637
2022-02-09—Atellica CH Fructosamine (Fruc), Siemens Material Number 11097637
2022-02-09—Atellica CH Calcium_2 (CA_2), Siemens Material Number 11097644
2022-01-28—Siemens Dimension Vista Magnesium Flex reagent cartridge (MG) Material # 10445158, Catalog # K3057
2021-12-01—Atellica CH 2-Microglobulin (B2M) -M) Assay for in vitro diagnostic use in the quantitative determin
2021-11-18—Atellica CH 930 Analyzer with Software version: V1.25.1 and lower- An automated, clinical chemistry
2021-10-15—Dimension Vista 1500 In-vitro diagnostic device intended to duplicate manual analytical procedures s
2021-10-15—Dimension Vista 500- In-vitro diagnostic device intended to duplicate manual analytical procedures s
2021-10-06—Aptio Automation Interface Module to ADVIA Centaur XP/XPT. Aptio by Siemens Centaur Interface Firmwa
2021-09-28—Atellica IM 1300 Analyzer, SMN 11066001
2021-09-28—Atellica IM 1600 Analyzer, SMN 11066000
2021-09-22—Atellica IM SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207861
2021-09-22—ADVIA Centaur SARS-CoV-2 Antigen Assay (100 Test Kit), SMN # 11207866
2021-09-20—Atellica CH Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11097543
2021-09-20—Advia Chemistry Urinary/Cerebrospinal Fluid Protein (UCFP), SMN 11319151
2021-07-06—Atellica IM BR 27.29 (BR) Assay 50 Test Kit- in vitro diagnostic use in the quantitative serial det
2021-07-06—Atellica IM BR 27.29 (BR) Assay 250 Test Kit (Reference)- in vitro diagnostic use in the quantitativ
2021-07-06—Atellica IM BR 27.29 (BR) Assay 250 Test Kit- in vitro diagnostic use in the quantitative serial det
2021-05-18—The ADVIA Chemistry XPT Chemistry System, Siemens Material Number (SMN) 10723034, is an automated, c
2021-05-13—Atellica CH 930 Analyzer - multi-component system for in vitro diagnostic testing of clinical speci
2021-05-13—Atellica IM 1600 Analyzer- multi-component system for in vitro diagnostic testing of clinical speci
2021-05-13—Atellica IM 1300 Analyzer - multi-component system for in vitro diagnostic testing of clinical spec
2021-05-04—Atellica CH 930 Analyzer with Photometer Lamp (SMN 11075676) Siemens Material Number: 11067000
2021-04-21—Centaur Syphilis Assay-SYP Kit, 200 Test - Product Usage: For in vitro diagnostic use in the qualita
2021-03-05—ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - OUS, automated hematology analyzer Software Ver
2021-03-05—ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - US, automated hematology analyzer Software
2021-03-05—ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - US, automated hematology analyzer So
2021-03-05—ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - US, automated hematology analyzer -automated
2021-03-05—ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - US, automated hematology analyzer Software Vers
2021-03-05—ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - US, automated hematology analyzer Softw
2021-03-05—ADVIA 2120 Dual Aspirate Autosampler (SMN 10313419) - OUS, automated hematology analyzer Software
2021-03-05—ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - US, automated hematology analyzer Software Ver
2021-03-05—ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - OUS, automated hematology analy
2021-03-05—ADVIA 2120 with Single Aspirate Autosampler (SMN 10316162) - OUS, automated hematology analyzer So
2021-03-05—ADVIA 2120i Dual Aspirate Autosampler (SMN 10285573) - OUS, automated hematology analyzer Software
2021-03-05—ADVIA 2120 REFURB DAA AUTOSAMPLER (SMN 10374454) - OUS, automated hematology analyzer Software Ver
2021-03-05—ADVIA 2120i with Single Aspirate Autosampler (SMN 10488923) - OUS, automated hematology analyzer S
2021-03-05—ADVIA 2120i Refurb Dual Aspirate (SMN 11314045) - OUS, automated hematology analyzer Software Vers
2021-03-05—ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - US, automated hematology analyzer
2021-03-05—ADVIA 2120i (RoHS) Dual Aspirate Autosampler (SMN 11219530) - OUS, automated hematology analyzer S
2021-03-05—ADVIA 2120 REFURB SAA AUTOSAMPLER (SMN 10374453) - US, automated hematology analyzer -automated he
2021-03-05—ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - US, automated hematology analyzer Software Ve
2021-03-05—ADVIA 2120i (RoHS) with Single Aspirate Autosampler (SMN 11219529) - US, automated hematology analy
2021-03-05—ADVIA 2120i Refurb Single Aspirate (SMN 11314044) - OUS, automated hematology analyzer Software Ve
2021-03-02—BCS XP System: Multipurpose system for in vitro coagulation studies. Product code: 10459330, 1046189
2021-02-08—Enzyme linked immunosorbent assay, for herpes simplex virus, hsv-2
2021-02-03—Dimension Vista HDLC - colorimetric method, lipoproteins - Product Usage: used as an aid in the diag
2020-12-02—Atellica IM 1300 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Mater
2020-12-02—Atellica CH 930 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Materi
2020-12-02—Atellica IM 1600 Analyzer - In vitro diagnostic testing of clinical specimens. Product Siemens Mater
2020-11-23—Atellica Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in th
2020-11-23—ADVIA Gamma-Glutamyl Transferase (GGT) Reagent - Product Usage: For in vitro diagnostic use in the q
2020-10-26—Atellica IM 1600 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in v
2020-10-26—Atellica IM 1300 Analyzer - Product Usage: automated, immunoassay analyzers designed to perform in v
2020-09-22—Atellica CH Systems Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurement
2020-09-22—ADVIA Chemistry Systems-Fructosamine (FRUC)-For in vitro diagnostic use in the quantitative measurem
2020-08-28—Siemens epoc BGEM Test Card-In vitro diagnostic device for the quantitative testing of samples of he
2020-08-25—Siemens Dimension Vista Akaline Phosphatase (ALPI) Flex reagent cartridge - In vitro diagnostic tes
2020-08-25—Atellica IM HER-2/neu (H2n) assay, 50 Test Kit, Catalog No. SMN 10995591, UDI Codes: (01)00630414599
2020-08-19—Dimension LOCI High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic use
2020-07-24—Dimension Vista High Sensitivity Troponin I (TNIH) Flex reagent cartridge-IVD-In vitro diagnostic us
2020-06-30—DCA Vantage Handheld Barcode Scanner - Zebra Model - Model # DS4308 - HC0015BZZWW external accessory
2020-06-05—Atellica CH Chemistry Calibrator
2020-06-05—ADVIA Chemistry Calibrator
2020-05-27—RP500e Handheld Barcode Scanner, Zebra Model: DS4308 - HC0062BZZWW, Siemens Material Number (SMN) 11
2020-05-15—Siemens IMMULITE 2000 XPi Immunoassay System - In vitro Chemistry Analyzer SMN #10373214 - Product U
2020-05-15—(1) CentraLink Data Management System software version 16.0.2 Siemens Material Number (SMN): 1131324
2020-05-15—Siemens IMMULITE 2000 Immunoassay System - In vitro Chemistry Analyzer SMN #10380062 - Product Usage
2020-05-15—(1) Atellica Data Manager software version 1.0 Siemens Material Number (SMN): 11314237 (2) Atellica
2020-05-07—Atellica Solution IM1300 Analyzer, Siemens Material Number 11066001, UDI # 00630414007960
2020-05-07—Atellica Solution IM1600 Analyzer, Siemens Material Number 11066000, UDI # 00630414002026
2020-05-04—Atellica CH Fructosamine Reagent (FRUC), Siemens Material Number 11097637, UDI Number 00630414595580
2020-05-04—Atellica CH Enzymatic Creatinine_2, Siemens Material Number 11097533, UDI Number 00630414595795 - Pr
2020-05-04—ADVIA Chemistry Enzymatic Creatinine_2, Siemens Material Number 10335869, UDI Number 00630414526690
2020-05-04—Dimension Enzymatic Creatinine, Siemens Material Number 10471520, UDI Number 00842768030512 - Produc
2020-05-04—ADVIA Chemistry Fructosamine Reagent (FRUC), Siemens Material Number 10361941, UDI Number 0063041455
2020-05-04—Dimension Vista Enzymatic Creatinine, Siemens Material Number 10700444, UDI Number 00842768036262 -
2020-02-27—Atellica CH 930 Analyzer, Siemens Material Number 11067000 with software version v1.21.0 SP1 or lowe
2020-02-14—Atellica CH Ethyl Alcohol, Test Code ETOH, Siemens Material Number (SMN) 11097501, UDI 0063041459611
2020-02-13—Atellica CH Direct Bilirubin_2 assay In vitro Diagnostic for the determination of direct bilirubin S
2020-02-13—Atellica CH Total Bilirubin_2 assay-In vitro Diagnostic for the determination of total bilirubin SM
2020-02-13—Dimension Vista Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination o
2020-02-13—Dimension Total Bilirubin Flex reagent cartridge -In vitro Diagnostic for the determination of tota
2020-02-13—ADVIA Chemistry Direct Bilirubin_2 assay-SMN: 10316610 (20 mL) & 10341114 (70 mL) - Product Usage:
2020-02-13—ADVIA Chemistry Total Bilirubin_2 assay- SMN: 10341115 (40 mL) & 10341113 (70 mL). Product Usage:
2020-02-05—IMMULITE 1000 Systems E2 Estradiol Catalog #: US: LKE21(D) and OUS: LKE21 - Product Usage: For in v
2020-02-05—IMMULITE 2000 Systems E2 Estradiol Catalog #: US: L2KE22(D) (200 tests) and L2KE26(D) (600 tests) an
2020-01-12—Atellica CH Reaction Ring Segment, SMN 11099326, UDI 00630414596143
2020-01-06—Atellica IM Humidity Pack (Qty 5), SMN 11313505, UDI 00630414234526, Software Version V1.21.0 and lo
2020-01-06—Atellica IM Humidity Pack (Qty 1), SMN 11313496, UDI 00630414243726, Software Version V1.21.0 and lo
2019-12-20—ADVIA Chemistry Lipase, Ref. No. 01984894 B01-4840-01, Siemens Material No. 10311896, UDI 0063041448
2019-12-18—Dimension Vista Enzymatic Creatinine (ECREA) reagent, SMN 10700444
2019-12-18—Atellica CH Enzymatic Creatinine (ECRE_2) reagent, SMN 11097533
2019-12-18—Dimension Enzymatic Creatinine (EZCR) reagent, SMN 10471520
2019-12-18—ADVIA Chemistry Enzymatic Creatinine (ECRE_2) reagent, SMN 10335869
2019-11-19—ADVIA Chemistry CardioPhase High Sensitivity C-Reactive Protein (hsCRP) Calibrator - product Usage:
2019-11-19—Atellica CH High Sensitivity C-Reactive Protein (HsCRP) Calibrator - Product Usage: For in vitro dia
2019-10-11—Atellica CH 930 Analyzer, Siemens Material Number 11067000, Software Versions V1.19.2 or 1.20.0 Th
2019-09-23—Atellica CH 930 Analyzer
2019-08-15—Atellica IM 1300 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066001
2019-08-15—Atellica IM 1600 Analyzer, (SW) version V1.19.0 and V1.19.2 Siemens Material Number (SMN): 11066000
2019-08-14—Atellica IM anti-CCP IgG (aCCP) Assay Siemens Material Number: 10732998 (100 Test) Test Version1.0 -
2019-07-30—Siemens Atellica CH 930 Analyzer. Siemens Material Number (SMN): 11067000 Product Usage: automat
2019-07-22—Siemens ADVIA Centaur Folate 100 test kit-for IVD of folate in serum or red blood cells SMN:10310308
2019-07-22—Siemens ADVIA Centaur Folate (500 Test Kit)-for IVD of folate in serum or red blood cells SMN: 10325
2019-07-22—Siemens ADVIA Centaur Folate (500 Test Kit Reference)- for IVD of folate in serum or red blood cell
2019-07-15—Dimension Ferritin (FERR) Flex reagent cartridge DM FERR Product Usage: The FERR Flex reagent cartr
2019-07-10—IMMULITE 1000 Progesterone, Model LKPW1, SMN Number 10381128
2019-07-10—IMMULITE 2000 Progesterone; Models US: L2KPW2, L2KPW6 and OUS: L2KPW2(D), L2KPW6(D); SMN Numbers US
2019-06-27—N Cuvette Segments for BN ProSpec System-IVD a system for the quantitative determination of proteins
2019-05-29—Stratus CS Acute Care cTNI TestPak, SMN 10445071 Product Usage: In vitro diagnostic test for the me
2019-05-03—Atellica CH Creatine Kinase (CK_L) Reagent, Product Code 11097640, UDI Number: 00630414006642 - Prod
2019-05-03—ADVIA Chemistry Creatine Kinase (CK_L) reagent, Product Code 10729780, UDI Number: 00630414008943 -
2019-03-07—Atellica IM 1300 Analyzer, Material Number 11066001
2019-03-07—Atellica Sample Handler Prime, Material Number 11069001
2019-03-07—Atellica IM 1600 Analyzer, Material Number 11066000
2018-12-12—Dimension Vista 1500, Analyzer, chemistry Model no. 10444801
2018-12-12—Dimension Vista 500, Analyzer, chemistry Model no. 10284473
2018-12-07—Atellica IM aTG (500 test kit) Siemens Material Number (SMN): 10995462
2018-12-07—Siemens Atellica IM aTG (100 test kit) Siemens Material Number (SMN): 10995461
2018-12-07—SiemensADVIA Centaur aTG (500 test kit) Siemens Material Number (SMN): 10492399
2018-12-07—Siemens ADVIA Centaur aTG (100 test kit) Siemens Material Number (SMN): 10492398
2018-10-16—Dimension Vista 500, model no. 10284473 an in vitro diagnostic device intended to duplicate manual a
2018-10-16—Dimension Vista 1500, Model No. 10444801 an in vitro diagnostic device intended to duplicate manual
2018-10-11—Dimension Vista Lactate Dehydrogenase (LDI) Flex reagent cartridge, an in vitro diagnostic test for
2018-09-28—Dimension Thermal Chamber Motor Cable located in the following models: Model/UDI Number: Dimension E
2018-09-26—Atellica IM 1600 Analyzer: In vitro diagnostic testing of clinical specimens - Product Usage: The At
2018-09-26—Atellica Sample Handler Prime. In vitro diagnostic testing of clinical specimens - Siemens Material
2018-09-26—Atellica IM 1300 Analyzer. In vitro diagnostic testing of clinical specimens. Siemens Material Numbe
2018-09-26—Atellica CH 930 Analyzer. In vitro diagnostic testing of clinical specimens Siemens Material Number
2018-09-07—Dimension Lipase Flex Reagent Cartridge, Model Number 10460277 Product Usage: Dimension - The LIPL
2018-09-07—Dimension Vista Lipase Flex Reagent Cartridge, Model Number 10461745 Product Usage: Dimension Vista
2018-08-14—STREAMLAB - REFRIGERATED STORAGE MODULE 15000
2018-08-14—APTIO 9000 REFRIGERATED STORAGE MODULE
2018-08-14—APTIO 15000 REFRIGERATED STORAGE MODULE
2018-08-14—STREAMLAB CORE UNIT / LYNX WITH IOM
2018-08-14—APTIO INPUT/OUTPUT MODULE
2018-08-14—APTIO RACK OUTPUT MODULE
2018-08-14—STREAMLAB - REFRIGERATED STORAGE MODULE 9000
2018-08-14—APTIO RACK INPUT MODULE
2018-08-14—APTIO CENTRIFUGE MODULE
2018-07-24—ADVIA Centaur CKMB Calibrator 2-pack Japan, Cat No. 02562748 Product Usage: For in vitro diagnostic
2018-07-24—ADVIA Centaur CKMB Master Curve Material, Cat No. 07867768 Product Usage: For in vitro diagnostic
2018-07-24—Atellica IM CKMB Calibrator, Cat No. 10995532 Product Usage: For in vitro diagnostic use for evalu
2018-07-24—ADVIA Centaur CKMB Calibrator, Cat No. 09318028 Product Usage: For in vitro diagnostic use in calib
2018-07-24—Atellica IM CKMB Master Curve Material, Cat No. 10995534 Product Usage: For in vitro diagnostic us
2018-07-16—RAPIDPoint 500 Blood Gas Analyzer; 10492730, 1069855, 10696857, 10697306 Device is point-of-care s
2018-07-16—RAPIDLab 1245 Blood Gas Analyzer; 10321844, 10337179, 10491393 Device is point-of-care system for
2018-07-16—RAPIDLab 1265 Blood Gas Analyzer; 110321852, 10470366, 10491395 Device is point-of-care system for
2018-07-16—RAPIDPoint 405 Blood Gas Analyzer; 10282093, 10310464, 10314817, 10317193, 10318999, 10320055, 10321
2018-06-29—Atellica Sample Handler Connect (SMN 11069018). The Atellica" Solution is a multi-component system f
2018-06-29—Atellica IM 1300 Analyzer (SMN 11066001). The Atellica" Solution is a multi-component system for in
2018-06-29—Atellica CH 930 Analyzer (SMN 11067000) . The Atellica" Solution is a multi-component system for in
2018-06-29—Atellica IM 1600 Analyzer (SMN 11066000). The Atellica" Solution is a multi-component system for in
2018-06-29—Atellica Sample Handler Additional (SMN 11069004). The Atellica" Solution is a multi-component syst
2018-06-29—Atellica Sample Handler Prime (SMN 11069001). The Atellica" Solution is a multi-component system fo
2018-04-19—Dimension Gentamicin Flex reagent cartridge, DM GENT, gentamicin enzyme immunoassay, Lot numbers af
2018-04-19—Dimension Vista Gentamicin Flex reagent cartridge, DV GENT, gentamicin enzyme immunoassay. Affected
2018-03-27—ADVIA Chemistry Urea Nitrogen Reagent (material number 10309051) for use on ADVIA 1800, 2400 and XPT
2018-03-21—Dimension Vista MULTI 2 SDIL, KD694, SMN# 10483586
2018-03-21—Dimension Vista CTNI Sample Diluent, KD692, SMN# 10445205
2018-03-21—Dimension Vista MULTI 1 SDIL, KD693, SMN# 10469971
2018-03-12—Syva EMIT II Plus 6-Acetyl morphine Catalog # for 28 mL: 9R039UL /SMN# 10470440
2018-03-12—Syva EMIT II Plus 6-Acetylmorphine Catalog # for 1000 mL: 9R129UL /SMN# 10481483
2018-02-26—Atellica Solution and Atellica Sample Handler Prime for in vitro diagnostic testing of clinical spec
2018-02-26—Atelia IM 1300 Analyzer for in vitro diagnostic testing of clinical specimens.
2018-02-26—Analyzer and Atellica IM 1600 Analyzer system for in vitro diagnostic testing of clinical specimens.
2018-02-21—ADVIA Centaur CA 125II Assay; Cat No. 09427226, SMN 10310443 (1-pack/100 tests); Cat no. 01678114, S
2018-01-30—Dimension Vista Calcium Flex reagent cartridge, Dimension Vista CA, K1023, SMN # 10445160 The CA me
2018-01-02—Dimension Vista Cardiac Troponin I (CTNI) Flex reagent cartridge
2018-01-02—IMMULITE /IMMULITE 1000 TG
2018-01-02—IMMULITE /IMMULITE 1000 Gastrin
2018-01-02—ADVIA Centaur DHEA-SO4
2018-01-02—Dimension Free Thyroxine (FT4L) Flex reagent cartridge
2018-01-02—IMMULITE 2000/IMMULITE 2000 XPi Anti HBc
2018-01-02—ADVIA Centaur HBc IgM
2018-01-02—Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge
2018-01-02—Dimension Thyroid Stimulating Hormone (TSHL) Flex reagent cartridge
2018-01-02—IMMULITE 2000/IMMULITE 2000 XPi TG
2018-01-02—Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
2018-01-02—ADVIA Centaur Folate (FOL)
2018-01-02—IMMULITE 2000/IMMULITE 2000 XPi OM-MA (CA125)
2018-01-02—IMMULITE 2000/IMMULITE 2000 XPi BR-MA (CA15-3)
2018-01-02—Dimension Sirolimus (SIRO) Flex reagent cartridge
2018-01-02—IMMULITE 2000/IMMULITE 2000 XPi 3g Allergy specific IgE Universal Kit
2018-01-02—IMMULITE /IMMULITE 1000 OM-MA (CA125)
2018-01-02—IMMULITE /IMMULITE 1000 BR-MA (CA15-3)
2018-01-02—IMMULITE /IMMULITE 1000 Vitamin B12
2018-01-02—IMMULITE /IMMULITE 1000 CEA
2018-01-02—IMMULITE 2000/IMMULITE 2000 XPi Folic Acid
2018-01-02—IMMULITE 2000/IMMULITE 2000 XPi CEA
2018-01-02—ADVIA Centaur Cyclosporine
2018-01-02—IMMULITE 2000/IMMULITE 2000 XPi Gastrin
2017-12-18—ADVIA Centaur BNP (B-type Natriuretic Peptide), Catalog Numbers: 02816138 (100 tests), 02816634 (500
2017-12-18—ADVIA Centaur TSH3-Ultra (Thyroid Stimulating Hormone 3 Ultra), Catalog Numbers: 06491072 (100 tests
2017-12-14—Dimension Lipase Flex Reagent Cartridge - ( Lipase-esterase, enzymatic, photometric, lipase)
2017-11-27—Syva EMIT 2000 Theophylline Product Usage: The Syva Emit 2000 Theophylline Assay is a homogeneous e
2017-11-09—Dimension Vista System LOCI 8 CALIBRATOR The LOCI 8 Calibrator is an in vitro diagnostic product f
2017-07-28—ADVIA Centaur T3 ADVIA Centaur T3: For in vitro diagnostic use in the quantitative determination of
2017-06-29—ADVIA Alanine Aminotransferase (ALT) reagent chemistry assays; ALT intended to measure the activity
2017-06-29—Dimension Aspartate Aminotransferase (AST) assay (Product Number: DF41A/10444959) (Mfr: Siemens Heal
2017-06-29—Syva Emit 2000 Sirolimus Assay (Product Number: 8S019UL/10445401) (Mfr: Siemens Healthcare Diagnosti
2017-06-29—Dimension Glucose (GLUC) assay (Product Number: DF40/10444973) (Mfr: Siemens Healthcare Diagnostics,
2017-06-29—Dimension Vista Glucose (GLU) assay; (Product Number: K1039/10445162) (Mfr: Siemens Healthcare Diagn
2017-06-29—Dimension Vista Ammonia (AMM) assay (Product Number: K3119/10711992) (Mfr: Siemens Healthcare Diagno
2017-06-29—ADVIA Ammonia (AMM) chemistry assay, an in vitro diagnostic device intended to quantitatively measur
2017-06-29—Dimension Thyroxine (T4) assay (Product Number: DF65/10444908) (Mfr: Siemens Healthcare Diagnostics,
2017-06-29—Dimension Alanine Aminotransferase (ALTI) assay; (Product Number: DF143/10475530) (Mfr: Siemens Heal
2017-06-29—Dimension Vista Creatine Kinase MB (MBI) assay; (Product Number: K3032/10464339) (Mfr: Siemens Healt
2017-06-29—Dimension Vista Thyroxine (T4) assay; (Product Number: K6065/10445101) (Mfr: Siemens Healthcare Diag
2017-06-29—Dimension Vista Aspartate Aminotransferase (AST) assay; (Product Number: K2014/10445148) (Mfr: Sieme
2017-06-29—Dimension Ammonia (AMM) assay; (Product Number: DF119/10711991) (Mfr: Siemens Healthcare Diagnostics
2017-06-29—Dimension Vista Alanine Aminotransferase (ALTI) assay; (Product Number: K2143/10635565) (Mfr: Siemen
2017-06-29—Dimension Creatine Kinase MB (MBI) assay (Product Number: DF32/10464510) (Mfr: Siemens Healthcare Di
2017-06-29—Syva Emit 2000 Tacrolimus Assay (Product Number: 8R019UL/10445397) (Mfr: Siemens Healthcare Diagnost
2017-06-29—ADVIA Salicylate (SAL) reagent chemistry assay; use in the quantitative determination of salicylate
2017-06-07—ADVIA Centaur Calibrator 30, 2 pack, 6 pack, and Ref 2 pack. Siemens Material Number (SMN): 10379810
2017-05-23—Dimension Vista Protein 1 Control, PROT 1 CON L, Siemens Material Number (SMN) 10445919, Product Co
2017-05-23—Dimension Vista Protein 1 Calibrator, PROT 1 CAL, Siemens Material Number (SMN) 10465664 (US) and 10
2017-05-23—Dimension Vista Protein 1 Control M, PROT 1 CON M, Siemens Material Number (SMN) 10445920, Product
2017-05-23—Dimension Vista Protein 1 Control H, PROT 1 CON H, Siemens Material Number (SMN) 10445921, Product
2017-04-10—RAPIDPoint 500 Blood Gas Analyzer with v2.4 software for professional use in a point-of-care or labo
2017-04-05—ADVIA Centaur Systems Insulin ReadyPack; Test Code: IRI; Catalog Number: 02230141, for in vitro diag
2017-04-05—ADVIA Centaur Systems Insulin Calibrator; Test Code: Calibrator IRI; Catalog Number: 04618899
2017-03-21—Dimension Vista Ferritin (FERR) Flex reagent cartridge
2017-03-21—Dimension Vista Digoxin (DIGXN) Flex reagent cartridge
2017-03-21—Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge
2017-03-21—Dimension Vista Estradiol (E2) Flex reagent cartridge
2017-03-21—Dimension Troponin 1 (TNI) Flex reagent cartridge
2017-03-21—Dimension Vista Prolactin (PRL) Flex reagent cartridge
2017-03-08—Siemens ADVIA Centaur BR assay Cat No. 03896216, SMN 10334837 (5-pack/250 tests) BR Assay for CA
2017-03-08—Siemens ADVIA Centaur BR assay Cat No. 02419937, SMN 10333349 (1-pack/50 tests) BR Assay for CA 2
2017-03-08—Siemens ADVIA Centaur BR assay Cat No. 09010686, SMN 10340081 (5-pack/250 tests - REF) BR Assay f
2017-03-03—Dimension Vista 500 Intelligent Lab System and Dimension Vista 1500 Intelligent Lab System, analyzer
2017-02-23—ADVIA Chemistry Enzyme 2 Calibrator, multi-analyte mixture Product Usage: Assays included in Enzyme
2017-02-02—ADVIA Centaur XPT System Software Versions V1.0.1, V1.0.2, V1.0.3, V1.1 and V1.2. The ADVIA Centaur
2017-01-31—SHBG IMMULITE 2000/IMMULITE 2000 XPi For the in vitro diagnostic use with the IMMULITE 2000 Systems
2017-01-11—N Latex HCY REAGENT, REF/Catalog OPAX03 /SMN 10445973 , IVD Product Usage: In-vitro diagnostic re
2017-01-10—Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 048
2017-01-10—Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 048
2017-01-10—Siemens ADVIA Centaur Systems Calibrator A Kits, Cat No. 04800646, SMN 10285903 (2 pack)Cat No. 048
2017-01-04—IMMULITE 2000 Progesterone; Catalog Number: L2KPW2 L2KPW6; Siemens Material Number: 10381181, 10381
2017-01-04—IMMULITE/ IMMULITE 1000 Progesterone; Catalog Number: LKPW1; Siemens Material Number: 10381128 Prod
2017-01-04—ADVIA Centaur Progesterone; Catalog Number: 10310305 10315522 10333111 Product Usage: The PROG meth
2017-01-04—Dimension Vista LOCI Progesterone; Catalog Number: K6464; Siemens Material Number: 10461743 Product
2016-12-21—IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LKUP1, SMN 10380956 (OUS Ki
2016-12-21—IMMULITE/IMMULITE 1000 Systems, Third Generation PSA, Catalog Number/REF LK3PS1, SMN 10706293 (US Ki
2016-12-16—Dimension Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagnostic
2016-12-16—Dimension Vista Ammonia Flex reagent cartridge / AMM Dimension: The AMM method is an in vitro diagno
2016-11-29—CentraLink Data Management System Software Versions: v13x,v14x,v15x The CentraLink system software
2016-11-22—SIEMENS IMMULITE 2000/2000 Xpi Systems Intact PTH (Parathyroid Hormone) Test Code iPTH, REF/Catalo
2016-11-18—IMMULITE/IMMULITE 1000 Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number LKPTS1, Sie
2016-11-18—IMMULITE 2000/IMMULITE 2000 XPi Systems Prostate-Specific Antigen (PSA) Assay, REF/Catalog Number L2
2016-10-21—ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD.
2016-10-19—ADVIA Centaur CA 19-9 Assay (250 test kit)-for use,with the ADVIA Centaur and ADVIA Centaur XP, ADV
2016-10-19—ADVIA Centaur CA 19-9 Assay (50 test kit)-for use, with the ADVIA Centaur and ADVIA Centaur XP, ADV
2016-10-07—Advia Chemistry Calibrator For in vitro diagnostic use in the calibration of ADVIA Chemistry system
2016-10-05—Siemens ADVIA Centaur Vitamin D Total Assay SMN SMN 10699533 (500 test)
2016-10-05—Siemens ADVIA Centaur Vitamin D Total Assay SMN 10699201 (100 test)
2016-09-29—FlexLab Automation Modules
2016-09-29—Aptio Automation Modules
2016-09-15—Dimension Vista Chemistry 1 Calibrator The Chemistry 1 Calibrator (KC110B) is an in vitro diagnostic
2016-09-02—Siemens RAPIDPoint 400 Measurement Cartridge Siemens SMN numbers:10329756, 10341161
2016-09-02—Siemens RAPIDPoint 405 Measurement Cartridge Siemens SMN numbers: 10844812, 1028322, 10313971 , 103
2016-08-30—IMMULITE 2000/IMMULITE 2000XPi Systems CMM CMV IgM Assay, REF/Catalog Number L2KCM2(D) - 200 tests (
2016-08-30—IMMULITE/ IMMULITE 1000 Systems CMM CMV IgM Assay, REF/Catalog Number LKCM1(D) - 100 tests (US), Sie
2016-08-25—Dimension Vista IRON Flex reagent cartridges
2016-08-25—Dimension IRON Flex reagent cartridges
2016-08-24—SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siem
2016-08-24—SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Ma
2016-08-11—Siemens RAPIDPoint 405 Blood Gas Analyzer nBili Siemens Material Number (SMN): 10282093, 10310464, 1
2016-08-11—Siemens RAPIDLab 1240 Blood Gas Analyzer Siemens Material Number (SMN): 10321840, 10491392
2016-08-11—Siemens RAPIDPoint 500 Blood Gas Analyzer Siemens Material Number (SMN): 10492730, 10696855, 10696
2016-08-11—RAPIDLab 1265 Blood Gas Analyzer Siemens Material Number (SMN): 10321852, 10470366, 10491395
2016-08-11—RAPIDLab 1260 Blood Gas Analyzer Siemens Material Number (SMN): 10321846, 10491394
2016-08-11—RAPIDLab 1245 Blood Gas Analyzer Siemens Material Number (SMN): 10321844, 10337179, 10491393
2016-08-11—Siemens RAPIDPoint 400 Blood Gas Analyzer Siemens Material Number (SMN): 10291507,10314585, 10318899
2016-08-09—ADVIA Centaur PSA Assay; Cat No. 06574155/SMN 10310292 (100 test)/02676506/SMN 10310293 (500 test)
2016-08-08—Siemens ADVIA Centaur Calibrator U, For in vitro diagnostic use in calibrating the following assays
2016-08-03—Dimension Vista Calcium (CA) Flex reagent cartridge Device Listing No.: D011443 Batch Number: 16060
2016-07-20—ADVIA Chemistry XPT, SMN 10723034, IVD. --- This issue affects only the ADVIA Chemistry Hemoglobin A
2016-07-05—Siemens RAPIDPoint 500 v2.2.2A Software Upgrade Kit; SMN 11066719, Software Version 2.2A The RAPIDPo
2016-06-22—Stratus CS STAT Fluorometric Analyzer-microprocessor-controlled instrument that measures certain ana
2016-06-17—ADVIA Chemistry (Syva Onboard) Theophylline_2 (THEO_2) Reagent is for in vitro diagnostic use in the
2016-06-17—Syva EMIT 2000 Theophylline - Catalog # 4P019UL /SMN#10445324 is a homogeneous enzyme immunoassay in
2016-05-26—ADVIA Centaur XPT system software versions V1.0.1 (Bundle 1.0.912 SMN 10819704), V1.0.2 (Bundle 1.0.
2016-05-11—Hettich Centrifuge Modules: StreamLAB Centrifuge Module (10372372 or 10444807 or 10706836) Aptio Cen
2016-05-05—The Enzyme 2 Calibrator is an in vitro diagnostic product for the calibration of Alanine Aminotransf
2016-05-05—The Enzyme II Calibrator is an in vitro diagnostic product for the Alanine Aminotransferase (ALTI) o
2016-05-02—Siemens Healthcare ADVIA Centaur Tnl-Ultra Assay . In-Vitro Diagnostic for quantitative determinatio
2016-04-28—ADVIA Centaur XPT Immunoassay System
2016-04-15—IG1, IGF-I reagent, Catalog # LKGF1; For the quantitative measurement of insulin-like growth factor
2016-03-30—ADVIA Centaur CP Immunoassay System, Siemens Material Number (SMN) 10309710, IVD. --- CLASSIFICATIO
2016-03-24—Dimension Vista 500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, Dev
2016-03-24—Dimension Vista 1500 Intelligent Lab System running on software versions V.3.6.1 SP1 or V.3.6.2, De
2016-03-17—Dimension Vista Assays: Direct HDL Cholesterol (AHDL)
2016-03-17—ADVIA CHEMISTRY GLUCOSE OXIDASE ASSAY AND ADVIA Chemistry Glucose & Concentrated Glucose Oxidase Ass
2016-03-17—Dimension Vista Assays: Triglycerides (TRIG)
2016-03-17—Advia Chemistry Assays - Cholesterol_2 concentrated and Cholesterol, LDL Cholesterol
2016-03-17—Advia Chemistry Assay: LDL Cholesterol, Direct
2016-03-17—Dimension Assays: ENZYMATIC CREATININE
2016-03-17—Dimension Vista Assays: Uric Acid (URCA)
2016-03-17—ADVIA CHEMISTRY ENZYMATIC CREATININE_2
2016-03-17—ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT & ADVIA CHEMISTRY TRIGLYCERIDES_2 Concentrated (TRI
2016-03-17—Dimension Vista Assays: Enzymatic Creatine (ECRE)
2016-03-17—Advia Chemistry Assay: Direct HDL Cholesterol (D-HDL)
2016-03-17—Dimension Assays: Direct HDL Cholesterol (AHDL)
2016-03-17—Advia Chemistry Assay: Uric Acid and Uric Acid, concentrated
2016-03-17—Advia Chemistry Assay: Lactate
2016-03-17—Dimension Assays: Uric Acid (URCA)
2016-03-17—Dimension Assays: Triglycerides (TGL)
2016-03-10—ADVIA 560 Hematology Systems, Siemens Material Number (SMN) 11170842, IVD The ADVIA 560 Hematology
2016-03-08—Syva Emit Methotrexate Assay, is a homogeneous enzyme immunoassay intended for use in the quantitati
2016-03-07—ADVIA Chemistry Triglyceride_2, concentrated; TRIG_c; Catalog # SMN # 10697575. For in vitro diagno
2016-02-16—Dimension Vista Blood Urea Nitrogen (BUN) Flex reagent cartridge The BUN method is an in vitro diag
2016-02-09—Dimension clinical chemistry system, Sirolimus (SIRO) Flex reagent cartridge (DF306 SMN 10464331) Lo
2016-02-04—Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E- 6- Pack Catalog Number: 04634762 SMN: 10
2016-02-04—Siemens Healthcare Diagnostics ADVIA Centaur Calibrator E - 2-Pack Catalog Number: 04634452 SMN:
2016-02-04—Siemens Healthcare Diagnostic ADVIA Centaur Calibrator E- 6- Pack (Reference) Catalog Number: 04636
2016-01-14—BCS XP Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation stu
2016-01-14—BCS Automated Blood Coagulation Analyzer System, Multipurpose system for in vitro coagulation studie
2016-01-13—Dimension Vista LOCI Estradiol Test Code E2 Catalog Number: K6463 SMN: 10489099 Product Usage: The
2016-01-13—IMMULITE 1000 Estradiol Test Code E2 Catalog Number: LKE21, LKE21(D), LKE25 SMN: 10381132, 10702832,
2016-01-13—Siemens ADVIA Centaur Enhance Estradiol Test Code eE2 Catalog Number: 10490889, 10491445, 10697757
2016-01-13—IMMULITE 2000 EstradiolTest Code E2 Catalog Number: L2KE22, L2KE22 (D), L2KE26, L2KE26 (D) SMN: 1038
2015-12-29—ADVIA Centaur PSA Assay; Catalog Number: 06574155/SMN 10310292 (100 test kit) and Catalog Number: 02
2015-11-19—Factor VIII Chromogenic Assay, REF/Catalog No. B4238-40, Siemens Material Number (SMN) 10445729, IVD
2015-11-11—Siemens Acute Care CKMB DilPak- an in vitro diagnostic product intended to be used in conjunction wi
2015-11-11—Siemens Acute Care CKMB TestPak- in vitro diagnostic test for the measurement of the MB isoenzyme o
2015-11-11—Siemens Acute Care DDMR TestPak Catalog Number: CDDMRE SMN: 10701511 in vitro diagnostic
2015-11-11—Siemens Acute Care CCRP CalPak-in vitro diagnostic product intended to be used for calibration of th
2015-11-11—Siemens Acute Care" MYO TestPak-in vitro diagnostic test for the quantitative measurement of myoglob
2015-11-11—Siemens Acute Care pBNP TestPak- in vitro diagnostic test for the quantitative measurement of N-term
2015-11-11—Siemens Acute Care" CCRP TestPak-in vitro diagnostic product intended to be used for calibration of
2015-11-11—Siemens Acute Care MYO DilPak Catalog Number: CMYO-D SMN:10445081 in vitro diagnostic
2015-11-11—Siemens Acute Care BHCG CalPak-in vitro diagnostic product intended to be used for calibration of th
2015-11-11—Siemens Acute Care CTNI TestPak-in vitro diagnostic test for the measurement of cardiac troponin I
2015-11-11—Siemens Acute Care BHCG TestPak-an in vitro diagnostic product intended to be used for calibration o
2015-11-10—Reagent Management System (RMS) Dimension EXL with LM Product Usage: The Reagent Management System
2015-11-10—Reagent Management System (RMS) Dimension EXL with LM STM Product Usage: The Reagent Management Sy
2015-11-10—Reagent Management System (RMS) Dimension RxL Max w/o HM Product Usage: The Reagent Management Syst
2015-11-10—Reagent Management System (RMS) Dimension RxL Max HM STM Product Usage: The Reagent Management Sys
2015-11-03—Dimension Vista System B2 Microglobulin Flex reagent cartridge and urine stabilizer Catalog #K702
2015-10-07—ADVIA Chemistry XPT Systems, Software Version 1.0.3, SMN 11127538 Clinical chemistry analyzer that
2015-09-30—Dimension Vista System (MG) ; Flex reagent cartridge Catalog number K3057, SMN 10445158. For the qua
2015-09-24—ADVIA Chemistry Hemoglobin A1c_3, A1c_3M Reagent kits. Used on the ADVIA 1200, 1650, 1800, 2400, a
2015-08-28—ADVIA Chemistry XPT Chemistry Systems, Siemens Material Number (SMN) 10723034. An automated, cli
2015-08-26—syngo Lab Data Manager System - Product Usage: syngo Lab Data Manager is a clinical system that assi
2015-08-24—Siemens RAPIDPoint 500 Measurement Cartridge Lactate (750 tests) Part Number: 10491449 Product Usag
2015-08-24—Siemens RAPIDPoint 500 Measurement Cartridge Lactate (100) tests Part Number: 10844813 Product Usag
2015-08-24—Siemens RAPIDPoint 500 Measurement Cartridge Lactate (400) tests Part Number: 10491448 Product Usag
2015-08-24—Siemens RAPIDPoint 500 Measurement Cartridge Lactate (250) tests Part Number: 10491447 Product Usag
2015-07-28—RAPIDPoint 500 Blood Gas Analyzer, Siemens Material Numbers (SMN):10492730, 10696855, 10696857, 1069
2015-07-27—ADVIA Centaur Folate Ascorbic Acid/Ascorbic Acid Diluent; SMN 10316877. Used to prepare the Red Bloo
2015-07-23—Dimension Vista B2-Microglobulin Flex Reagent Cartridge (B2MIC); Product Usage: The B2MIC method
2015-07-15—Dimension CREA (Creatinine) and Dimension Vista CREA (Creatinine); The CREA method used on the Dime
2015-06-30—ADVIA Chemistry Acetaminophen reagents; for in vitro diagnostic use in the quantitative determinatio
2015-05-21—Siemens Healthcare Diagnostics Dimension Vista Systems, used with the Dimension Vista Intelligent La
2015-05-19—CentraLink" Data Management System; software is a network solution provider and multi-system data ma
2015-05-19—ADVIA Centaur Tni-Ultra Assay; SMN 10317708 - 100 tests and SMN 10317709 -500 tests Product Usage:
2015-05-11—Factor deficient plasma for the Siemens BCS / BCS XP System. In vitro diagnostic reagent for the de
2015-05-06—The Rapidlab 1260 system is a blood gas analyzer used for laboratory testing of blood gases, electro
2015-05-06—The Rapidlab 1265 system is a blood gas analyzer used for laboratory testing of blood gases, electro
2015-05-06—IMMULITE 2000/IMMULITE 2000 XPi Italian Cypress 3g Allergy, Catalog # T23L4 (40 test), Siemens Mater
2015-04-29—EasyLink Data Management System; a clinical data management system that assists medical laboratory p
2015-04-20—Dimension Vista Systems LOCI Thyroid Stimulating Hormone; the TSH method is an in vitro diagnostic t
2015-04-09—IMMULITE/IMMULITE 1000 Systems TBG, catalog LKTB1 Quantitative measurement of Thyroxine-Binding Glo
2015-04-02—Dimension EXL with LM, Dimension EXL 200, Dimension RxL, Dimension RxL HM, Dimension RxL Max, Dimens
2015-03-25—Dade Actin Activated Cephaloplastin Reagent; Liquid rabbit brain cephalin with plasma activator for
2015-03-23—ADVIA Chemistry Lipase Reagent , Catalog Number B01-4840-01 REF: 01984894.
2015-02-24—QuikLYTE Dilution Check: used to monitor and adjust for the dilution ratio on Dimension clinical che
2015-02-11—ADVIA Chemistry XPT System, Siemens Material Number 10723034, Software Version 1.0.2, Siemens Materi
2015-01-27—ADVIA Centaur Systems Progesterone Kit, (1 -pack) In Vitro Diagnostic; Catalog number: 02382928; SMN
2015-01-27—ADVIA Centaur Systems Progesterone Kit, (5 -pack); In Vitro Diagnostic; Catalog number: 01586287; SM
2015-01-27—ADVIA Centaur Systems Progesterone Kit, (5-pack Ref); In Vitro Diagnostic Catalog number: 02177364;
2015-01-22—Siemens Healthcare Caps for capillary 50/60 uL, Package count 200 For use with blood collection Mul
2015-01-22—Siemens Healthcare Caps for capillary 140/175 uL, Package count 100 For use with blood collection
2015-01-22—Siemens Healthcare Caps for capillary 100 uL , Package count 200 For use with blood collection Multi
2015-01-19—ADVIA Chemistry Systems Drug Calibrator I; For in vitro diagnostic use in the calibration of Phenoba
2015-01-15—N Latex IgM; In-vitro diagnostic reagent for the quantitative determination of IgM in human cerebros
2014-12-30—RAPIDPoint 500 Blood Gas Analyzer; Siemens Material Number: 10492730, 10696855, 10696857, 10697306.
2014-12-30—RAPIDLab 1265 System; Siemens Material Number: 10491395, 10321852, 10335524. The Rapidlab 1200 sys
2014-12-30—RAPIDPoint 405 Blood Gas Analyzer; Siemens Material Number: 10310464, 10322347, 10314817, 10317193,
2014-12-30—RAPIDLab 1245 System; Siemens Material Number: 10321844, 10491393, 10337179. The Rapidlab 1200 sys
2014-12-16—ADVIA Chemistry XPT interfaced to the CentraLink Data Management System V14x in specific configurat
2014-11-24—Dimension Vista Myoglobin Calibrator (MYO CAL), Lot 4FD085 Product usage: in vitro diagnostic prod
2014-11-05—Dimension Vista 500 Intelligent Lab System or Dimension Vista 1500 Intelligent Lab System: An in v
2014-10-27—Turbo Troponin I For in vitro diagnostic use for the quantitative measurement of troponin I in seru
2014-10-20—IMMULITE Calcitonin Control Module (IMMULITE, IMMULITE 1000, IMMULITE 2000, IMMULITE 2000 XPi) For
2014-10-17—Rapid Neg Urine Combo Panel Type 1; Catalog number B 1017-167; Siemens Material Number 10444652 Mic
2014-10-17—Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for
2014-10-09—ADVIA Centaur XP Immunoassay System (including refurbished) Professional use in a laboratory for in
2014-10-09—ADVIA Centaur (including refurbished) Professional use in a laboratory for in vitro diagnostic test
2014-10-06—ADVIA Centaur BNP Assay for in vitro diagnostic use in the quantitative determination of B-type Natr
2014-09-30—Siemens Dimension HB1C Flex reagent cartridge; Dimension Hemoglobin A1c (HB1C) Flex reagent cartridg
2014-09-26—Siemens Calibrator E; SMN 10309079 (2 pack), SMN 10321075 (6 pack), SMN 10335532 (6 pack Ref)
2014-09-24—siemens Dimension Phenytoin Flex Reagent Cartridge The PTN method used on the Dimension clinical ch
2014-09-19—External power supply adaptors that accompany Clinitek Status Connect System The Clinitek Status sy
2014-09-19—External power supply adaptors that accompany Clinitek Status Power Supply Adaptor - Spare Part The
2014-09-19—External power supply adaptors that accompany Clinitek Status+ The Clinitek Status systems is a uri
2014-09-15—ADVIA Centaur Systems HBc Total (HBcT) Kit. For In Vitro Diagnostic Use. Catalog Number: 07566733 Si
2014-09-15—Siemens ADVIA Centaur Systems HBc Total (HBcT), Reagent. For In Vitro Diagnostic Use Catalog Number:
2014-09-12—ADVIA Centaur and ADVIA Centaur XP and ADVIA Centaur CP Cleaning Solution (For in vitro diagnostic u
2014-08-28—Dimension Vista Mass CKMB Isoenzyme Calibrator (MMB CAL) an in vitro diagnostic product for the cali
2014-08-19—Siemens CentraLink Data Management System, software version 14. The CentraLink system software is
2014-08-18—Siemens Dimension Vista CHEM 1 CAL, lot 3GM081. The CHEM 1 CAL is an in vitro diagnostic product fo
2014-08-14—Dimension Vista HbA1c
2014-07-16—Siemens Dimension EXL Integrated Chemistry System in vitro diagnostic devices intended to measure a
2014-07-15—Siemens Dimension Chemistry Wash (RD701) is an accessory of the flex cartridge system used on the Si
2014-06-23—SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309045 - 500 test For in vitro diagnosti
2014-06-23—SIEMENS ADVIA Centaur CP Immunoassay System BNP kit; SMN 10309044 - 100 test For in vitro diagnosti
2014-06-09—Coat-A-Count Direct Androstenedione, SMN 10381049, Catalog Number TKAN1. Siemens Healthcare Diagnos
2014-06-02—Siemens Healthcare ADVIA Acid/Base Reagent 1 and 2 Kit containing ADVIA Centaur Acid Reagent bottles
2014-06-02—MicroScan WalkAway-40 plus Instrument and MicroScan Walkaway-96 plus instrument access door hinge.
2014-05-30—ADVIA Centaur Systems TnI-Ultra assay; Catalog Number 02789602 (100 tests), SMN 10317708 and 0279030
2014-05-27—Dimension Integrated Chemistry Systems intended to measure a variety of analytes in human body fluid
2014-05-23—RAPIDPoint 500 Measurement Clinical Chemistry System RAPIDPoint 500 Measurement Cartridge Lactate (7
2014-05-22—Siemens RAPIDComm Data Management System. The RAPIDComm Data Management System manages the process
2014-05-20—syngo Lab Data Manager, SMN 10800057, 10803189, and 10804573.
2014-04-14—Siemens Healthcare Diagnostics Vista Air Compressor. Vista AirCompressor replacement part: SMN 107
2014-04-10—ADVIA Centaur Systems TSH3 Ultra 2500 tests Catalog Number: 04862625; Siemens Material Number (SMN)
2014-04-10—ADVIA Centaur Systems VitD 100 test, Ready Pack, Catalog Number: 10491994. Intended for the invitro
2014-04-10—ADVIA Centaur Systems TSH3 Ultra , Ready Pack, 500 test Catalog Number: 06491080; Siemens Material N
2014-04-10—ADVIA Centaur Systems VitD Total 100 test, Ready Pack, For OUS; SMN 10699201. Intended for the inv
2014-04-10—ADVIA Centaur Systems TSH3 Ultra Ready Pack, 100 test Catalog Number: 06491072; Siemens Material Nu
2014-04-10—ADVIA Centaur Systems VitD 500 test, Ready Pack, Catalog Number: 10631021. Intended for the invit
2014-04-10—ADVIA Centaur Systems BRAHMS PCT 100 test Sold only OUS; Catalog Number: 10378883.
2014-03-25—Siemens ADVIA Centaur Folate Cat No. 06891541 SMN 10325366 (500 tests) Cat No. 06367974 SMN 1031030
2014-03-19—Dimension Vista CSA and CSAE The Cyclosporine method is an in vitro diagnostic test for the quantit
2014-01-06—Dimension Vista Enzyme 1 Calibrator (ENZ 1 CAL) lots 3FD034 and 3HD012. An in vitro diagnostic mult
2013-12-18—ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 6-pack SMN 10314977 For in vitro diagnostic u
2013-12-18—ADVIA Centaur Systems Phenytoin Calibrator N ( PHTN) 2-pack SMN 10311391 For in vitro diagnostic us
2013-12-17—Siemens ADVIA 1200 and ADVIA 1650 Chemistry Systems. Automated, clinical chemistry analyzers that c
2013-12-05—Dimension Vista Cyclosporine Flex reagent cartridge an in vitro diagnostic test for the quantitativ
2013-11-06—Siemens ADVIA Chemistry Systems models 1200, 1650, 1800 and 2400 Product Usage: The ADVIA Chemistry
2013-10-30—Siemens CentraLink" Data Management System V14.0.4, V14.0.5 or V14.0.8 The CentraLink system softwa
2013-10-07—User Defined Method Flex Assignment/Siemens Dimension Vista 500 or Dimension Vista 1500 System with
2013-09-18—Siemens Dimension Vista Homocysteine Flex Reagent Cartridge The HCYS method is an in vitro diagnost
2013-09-17—Siemens Dimension LOCI TNI Troponin I Calibrator RC 621. The LOCI TNI Troponin I Calibrator is
2013-08-30—Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay
2013-08-21—Microscan Synergies Plus Negative Urine Combo 2 Product Usage: MicroScan Synergies plus Panels & Mi
2013-08-21—Microscan Synergies Plus Negative Breakpoint Combo 7 Product Usage: MicroScan Synergies plus Panels
2013-08-21—Microscan rapID/S panels NC3.33 Sold in Japan only. Product Usage: MicroScan Synergies plus Panel
2013-08-21—Microscan plus Negative Urine Combo 4 Sold outside of US only. Product Usage: MicroScan Synergies
2013-08-21—Microscan Synergies Plus Negative Urine Combo 5 Product Usage: MicroScan Synergies plus Panels & M
2013-08-21—MicroscanrapID/S panels NC3.11 Sold in Japan only. Product Usage: MicroScan Synergies plus Panels
2013-08-21—Microscan rapID/S panels NC3.12 Sold in Japan only. Product Usage: MicroScan Synergies plus Panel
2013-08-21—Microscan Synergies Plus Negative Combo 2 Product Usage: MicroScan Synergies plus Panels & MicroSc
2013-08-21—Microscan Synergies Plus Negative Urine Combo 1 Product Usage: MicroScan Synergies plus Panels & Mi
2013-08-21—Microscan plus Negative Breakpoint Combo 4 Sold outside of US only. Product Usage: MicroScan Syner
2013-08-21—Microscan plus Negative Combo 3 Sold outside of US only. Product Usage: MicroScan Synergies plus P
2013-08-16—ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic
2013-08-13—Siemens EasyLink Informatics System V4.0/V5 Siemens, Material Number (SMN) 10444799, 10444800, 10487
2013-07-25—ADVIA Centaur Folate (500 tests), REF SMN 10331250, Cat No. 00203473 In vitro diagnostic use in the
2013-07-25—ADVIA Centaur Folate (2500 tests), REF SMN 10340209, Cat No. 09132781 In vitro diagnostic use in th
2013-07-25—ADVIA Centaur Folate (500 Tests) SMN 10325366, Cat No. 06891541 In vitro diagnostic use in the quan
2013-07-25—ADVIA Centaur Folate (100 Tests), SMN 10310308, Cat No. 06367974 In vitro diagnostic use in the qu
2013-07-01—Dimension Tacrolimus Flex reagent cartridge (DF107) and Dimension TACR CAL (DC107) Product Usage:
2013-06-28—ADVIA Centaur Calibrator A. Cat. #04800735, SMN 10285904 (6 pack); Cat. # 04800840, SMN 10285905 (6
2013-06-25—ADVIA Centaur HCY Diluent - 10mL Bottle Catalog number 09877493 (124533), SMN 10310370, and Ancillar
2013-06-19—Dimension Vista 500 and Dimension Vista 1500 System Aliquot Well Double Dispense with software vers
2013-06-05—Dimension(R) Mass Creatine Kinase MB Isozyme Calibrator (RC420) The Mass Creatine Kinase MB isozyme
2013-05-20—Dimension Vista(R) 500 and Dimension Vista(R) 1500 - Reloaded Vista Vials - limited to systems using
2013-05-14—ADVIA Centaur iPTH ReadyPack Assay 100 Tests; REF 10492368. For in vitro diagnostic use in the quan
2013-05-14—ADVIA Centaur iPTH Calibrator 6 pk; REF: 10492387, 10630628. For in vitro diagnostic use in calibr
2013-05-14—ADVIA Centaur iPTH ReadyPack Assay 500 Tests; REF 10492369, 10493615, 1049361. For in vitro diagnos
2013-05-14—ADVIA Centaur iPTH Calibrator 2 pk; REF 10492394. For in vitro diagnostic use in calibrating Intact
2013-05-10—ADVIA Centaur Systems TSH3 Ultra ReadyPack ((REF 06491072 - 100 Tests, REF 06491080 - 500 Tests, REF
2013-05-10—syngo(R) Lab Data Manager - Version VA11B and VA12A Systems Securely consolidates data from multipl
2013-05-10—IMMULITE Systems Third Generation TSH (REF LKTS1 - 100T, LKTS5 - 500T, L2KTS2 - 200T, L2KTS6 - 600T)
2013-05-10—Dimension TSH Flex Reagent Cartridge (REF RF412). Intended to quantitatively measure human thyroid
2013-05-10—Dimension Vista System TSH Flex Reagent Cartridge (REF K6412). Intended to quantitatively measure h
2013-05-10—IMMULITE Systems Rapid TSH (REF LKRT1 - 100T, LKRT5 - 500 T, L2KRT2 - 200T, L2KRT6 - 600T). Intende
2013-05-10—Dimension EXL LOCI Module TSHL Flex Reagent Cartridge (REF RF612). Intended to quantitatively measu
2013-05-06—Dimension(R) Chemistry Wash (RD701), Siemens Material Number (SMN) 10445052 Product Usage: Used i
2013-05-02—Siemens brand MicroScan Dried Negative Breakpoint Combo 47 panels (B1017-417), SMN #: 10483099), F
2013-04-25—Dimension(R) TACR Flex(R) reagent cartridge (DF107) The TACR method is an in vitro diagnostic test
2013-04-22—HB1C Flex(R) Reagent Cartridge (DF105A, Siemens Material Number 10483822) for the Dimension(R) Clini
2013-04-22—HbA1c Flex(R) reagent cartridge (K3105A, Siemens Material Number 10470481) for the Dimension(R) Clin
2013-03-13—ADVIA Centaur Vitamin D Calibrator 6-pack; Reference Number:10630911. For use in the quantitative d
2013-03-13—ADVIA Centaur Vitamin D Calibrator 2-pack; Reference Number:10493589. For use in the quantitative d
2013-03-13—ADVIA Centaur Vitamin D Assay (100 tests); Reference Number: 10491994. For use in the quantitative
2013-03-13—ADVIA Centaur Vitamin D Assay (500 tests); Reference Number:10631021. For use in the quantitative d
2013-03-11—Dade(R) Actin(R) FSL Activated PTT Reagent. For use in the determination of the activated partial t
2013-03-06—Siemens Healthcare Diagnostics Inc. MIcroScan MICroSTREP plus Type 1 B1027-201 panels. .MICroSTREP
2013-02-27—Siemens Dimension(R) EXL(TM) LM (Siemens Material Number 10486890). Intended to measure a variety o
2013-02-27—Siemens Dimension(R) EXL(TM) 200 (Siemens Material Number 10636929). Intended to measure a variety
2013-02-27—Siemens Dimension(R) EXL(TM) LM STM (Siemens Material Number 106393377). Intended to measure a vari
2013-02-26—CLINITEK Status+ Analyzer (portable urine chemistry analyzer). Catalog number 10490946.
2013-02-22—Siemens Dimension(R) Phosphorus (PHOS) Flex(R) reagent cartridge (DF61) The Phosphorus (PHOS) metho
2013-02-21—Siemens Dimension Vista(R) System Vista Drug 4 Calibrator. The device is used as an in vitro diagnos
2012-12-20—Dimension(R) IRON Calibrator (DC85), Siemens material number 10445010. The Dimension(R) IRON Calibr
2012-12-20—Siemens Total Iron Binding Capacity (IBCT) Flex Reagent Cartridge. An in vitro diagnostic test in
2012-12-19—Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349B
2012-12-10—Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL). Homo
2012-12-06—Siemens Emit(R) tox(TM) Serum Calibrators, catalog number 7B019UL The Emit(R) tox(TM) Serum Calibra
2012-11-27—Siemens Dimension(R) Tacrolimus Flex(R) reagent cartridge (DF107). The TACR method is used as an in
2012-11-21—Siemens Chek-Stix Combo Pak Catalog Number: 1364 Chek-Stix Positive and Negative Control Strips fo
2012-11-21—Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364M Chek-Stix Positive and Neg
2012-11-21—Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry (Distributed OUS Only) Ca
2012-11-21—Siemens Chek-Stix Combo Pak (Distributed OUS only) Catalog Number: 1364N Chek-Stix Positive and Ne
2012-11-21—Siemens Chek-Stix Combo Pak (Distributed OUS) Catalog Number: 1364E Chek-Stix Positive and Negative
2012-11-21—Siemens Chek-Stix Positive and Negative Control Strips for Urine Chemistry Catalog Number:1360 Chek
2012-11-21—Siemens CLINITEK Atlas Positive and Negative Control Strips for Urine Chemistry Catalog Number: 5019
2012-11-14—Siemens Healthcare BR Assay for CA 27.29 250 Test Kits 03896216 50 Test Kit 02419937 Ref Kit (US onl
2012-11-14—Siemens Healthcare ADVIA Centaur Theophylline 2 (THE02) 250 Test 08838753 50 Test
2012-11-14—Siemens Healthcare ADVIA Centaur Digitoxin (DGTN) 250 Test 09046419 50 Test 08
2012-11-14—Siemens Healthcare ADVIA Centaur Folate (FOL) 500 Test 06891541 100 Test 06367
2012-11-14—Siemens Healthcare ADVIA Centaur DHEA-504 (DHEAS) 50 Test 06489701 The ADVIA Centaur DHEAS assay is
2012-11-14—Siemens Healthcare ADVIA Centaur CA 19-9 250 Test 10491244 50 Test 10491379 Intended Use The ADVIA
2012-11-14—Siemens Healthcare BNP (8-type Natriuretic Peptide) 500 Test kit 02816634 100 Test 02816138 103090
2012-10-11—Siemens StreamLAB(R) Analytical Workcell; Catalog number 746002.901. Designed to automate sample ha
2012-10-10—Siemens Dimension Vista(R) Alkaline Phosphatase (ALP) Calibrator The ALP CAL is an in vitro diagnos
2012-10-09—ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
2012-10-09—ADVIA Centaur Ferritin Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur
2012-10-09—ADVIA Centaur Calibrator C-Used with the ADVIA Centaur Ferritin assay on the ADVIA Centaur CP system
2012-10-08—Dimension Vista(R) IRON Flex(R) reagent cartridge (K3085) The IRON method is an in vitro diagnostic
2012-09-17—Siemens RAPIDLab 1265 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidla
2012-09-17—Siemens RAPIDLab 1260 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidla
2012-09-17—Siemens RAPIDPoint 400 system blood gas analyzer Product Usage: These systems are intended for near
2012-09-17—Siemens RAPIDLab 1245 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidl
2012-09-17—Siemens RAPIDPoint 500 system blood gas analyzer Product Usage: RAPIDPoint 500 System: The RAPIDPoi
2012-09-17—Siemens RAPIDPoint 405 system blood gas analyzer Product PUsage: These systems are intended for nea
2012-09-17—Siemens RAPIDLab 1240 system blood gas analyzer Product Usage: RAPIDLab 1200 Systems: The Rapidla
2012-09-11—Siemens ADVIA Centaur BR Assay: Catalog Number: US: REF 02419937 (10214722) (50 Tests); REF 03896216
2012-08-09—Dimension Vista(R) Systems Vista(R) Theophylline THEO Flex(R) Regent Cartridge (K4071) The THEO met
2012-08-07—ADVIA Centaur FSH Assay: ADVIA Centaur Calibrator B US: Calibrator B 00652707 (6 pack) or 00649625
2012-08-07—ADVIA Centaur Prolactin Assay: ADVIA Centaur Calibrator B Catalog Number. Prolactin:110757 and 11075
2012-08-03—Siemens Dimension Vista(R) Homocysteine Flex(R) Reagent Cartridge This is an in vitro diagnostic te
2012-07-30—Emit(R) 2000 Phenobarbital Assay (OSR4D229) and Syva(R) Emit(R) Phenobarbital Assay (4D019UL) Produ
2012-07-25—Siemens ADVIA Centaur Multi-Diluent 1 - Used for automated dilutions for the ADVIA Centaur BNP and T
2012-07-17—Siemens ADVIA Centaur Syphilis (SYPH) Assay , 200 ReadyPack Reference Number 10492493 Product Usa
2012-07-17—Dimension(R) Reagent Management System (RMS) - Power Cord. The Siemens Healthcare Diagnostics Dimen
2012-07-17—Dimension Vista(R) Vancomycin Flex(R) Reagent Cartridge (VANC, Catalog # K4086). For the quantitati
2012-06-07—Siemens syngo(R) Lab Data Manager. The syngo(R) Lab Data Manager is classified as a data calculator
2012-06-07—EasyLink(TM) Informatics System, Part Number 1000034805. EasyLink(TM) Informatics System is classifi
2012-06-07—Siemens Stratus(R) CS Acute Care(TM) D-dimer Calibrator (DDM CalPak) lots 502058002 and 501318002 T
2012-05-29—EasyLink Informatic System is included with the Dimension Vista System. The Dimension Vista Integra
2012-05-29—syngo(R) Lab Data Manager and syngo(R) Lab Process Manager, all versions. This device is classified
2012-05-08—Siemens Dimension Vista(R) System B12 Flex(R) Reagent Cartridge (K6442) B12 Flex Reagent Cartridge
2012-04-05—Stratus(R) CS Acute care(TM) NT - proBNP TestPak reagent (CPBNPM) The Stratus(R) CS Acute care(TM)
2012-04-02—Dimension Vista(R) Total Prostate Specific Antigen Flex(R) reagent cartridge Product Usage: The TPS
2012-03-06—Siemens ADVIA Centaur Cortisol Assay Cat. Nos. 04610138 (1 0321 026)- 250 Test kit 04610049(10309078
2012-02-17—Dimension Vista(R) MG Flex(R) Reagent Cartridge The Dimension Vista(R) MG method is an in vitro dia
2012-02-16—Siemens ADVIA Centaur Vitamin D Diluent 2-pack, Reference 10494100 in vitro diagnostic use in the qu
2012-01-16—Siemens Healthcare Diagnostics Dimension Vista(R) software version 3.4 The Dimension Vista(R) Syste
2011-12-19—Dade(R) Actin(R) FSL Activated PTT Reagent Product Usage: Liquid purified soy and rabbit brain pho
2011-12-02—EasyLink(TM) Informatics Systems Software Version 5.0 and Software Version 5.0 Service Packs 1 throu
2011-11-22—Dimension(R) Creatinine Flex(R) Reagent Cartridges. The CREA method is an in vitro diagnostic test
2011-11-17—Siemens Healthcare Diagnostics, Dimension Vista(R) Cardiac Troponin I Calibrator (KC678) lot 1DD085,
2011-11-11—ADVIA Centaur CA19-9 Assay Cat. Nos. 123521 (03481938) - 250 Test kit w/o Calibrators 123519 (046127
2011-10-31—Dimension(R) Vista(R) V-LYTE(R) Diluent (K835) Product Usage: V-LYTE(R) Diluent is for the automat
2011-10-31—Dimension(R) Vista(R) V-LYTE(R) Standard B/Salt Bridge (K825) Product Usage: V-LYTE(R) Standard B/
2011-10-31—Dimension(R) Vista(R) V-LYTE(R) Standard A (K820) Product Usage: V-LYTE(R) Standard A is for the c
2011-08-31—Dimension(R) EXL LOCI Cardiac Troponin I Calibrator (RC621) The LOCI Cardiac TNI Calibrator is an i
2011-08-31—Siemens Healthcare Diagnostics, Inc. Dimension(R) EXL Cardiac Troponin I Flex(R) Reagent Cartridges
2011-08-08—Dimension Vista(R) Cuvettes The Dimension Vista(R) Cuvettes are for use on the Dimension Vista(R)
2011-07-19—Dimension Calcium Flex Reagent is used on the Dimension clinical chemistry system as an in vitro dia
2011-06-16—MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Urine Combo 55; Catalog Number B101
2011-06-16—MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 34, catalog n
2011-06-16—MicroScan Dried Overnight Gram Negative Panels; Panel type: Neg Breakpoint Combo Type 47, catalog n
2010-12-27—Dimension(R) Creatinine Flex(R) Reagent Cartridges The CREA method is an in vitro diagnostic test f
2010-12-23—Stratus(R) CS Acute Care Troponin I TestPak, Troponin I Assay The Stratus(R) CS Acute CareTM Tropon
2010-12-14—ADVIA Centaur CA 125 II Assay packaged in 100 and 500 test kits as follows: Product code: 09427226 (
2010-12-01—BCS(R) Behring Coagulation System, Device catalog No. OVIO03 Product Usage: Multipurpose system fo
2010-11-30—Dimension Vista(R) Gentamicin (GENT) Flex(R) reagent cartridge, K4012 This method is an in vitro dia
2010-08-19—Dimension Vista V-LYTE Standard A, Catalog No K820 For the calibration of Na+/K+/Cl- on the Dimensio
2010-07-23—EasyLink Informatics Systems QCFIRST Custom Rule The EasyLink Informatics System is classified as a
2010-06-15—Dimension Tacrolimus Flex Reagent Cartridge, manufactured by Siemens Healthcare Diagnostics Inc., Ne
2010-06-10—Siemens Dimension(R) EZCR Flex(R) Reagent Cartridge. Catalog number DF270B. In vitro diagnostic te
2010-06-10—Enzymatic Creatinine (ECREA) Flex(R) reagent cartridges, K1270 for the Dimension Vista(R) 500 System
2010-05-05—Siemens Healthcare Diagnostics, Inc., Dimension Vista Intelligent Laboratory System with Alpha Pinna
2010-04-13—Stratus CS Acute Care Troponin I TestPak ( Troponin I assay)
2010-04-12—The Dimension TNI Flex reagent cartridge (Cardiac Troponin), manufactured by Siemens Healthcare Diag
2010-04-12—The Dimension TSHL Flex reagent cartridge (Thyroid Stimulating Hormone) manufactured by Siemens Heal
2010-04-12—The Dimension FT4L Flex reagent cartridge( Free Thyroxine) manufactured by Siemens Healthcare Diagno
2010-04-12—The Dimension NTP and LNTP Flex reagent cartridge (N- Terminal Pro- Brain Natriuretic Peptide and N-
2010-03-15—Siemens Healthcare Diagnostics, Dimension Vista LOCI Reaction Vessels, catalog number KS855. For in
2010-03-10—Dimension LIP Flex Reagent Cartridge, Catalog# DF55A
2010-02-26—Dimension Vista Chemistry 2 Calibrator, Catalog number KC120. Used to calibrate Phosphate, Salicyla
2010-02-12—Dimension Vista ECREA Flex Reagent Cartridge The ECREA method is an in vitro diagnostic test for the
2009-12-16—Dimension IBCT Flex Reagent Cartridge. The total (IBCT) method used on the Dimension system is an in
2009-12-07—Stratus(R) CS Rotors, catalog number CROTOR, lot number NH42-251-09 Intended use: Stratus(R) rotors
2009-11-24—Dimension Vista LOCI Reaction Vessel
2009-10-30—RapidPoint 400 Analyzers for Blood Gas, Electrolytes and metabolites Software Versions prior to 3.5.
2009-10-30—RapidPoint 405 System Analyzers The RP405 is capable of testing all of the analytes listed below in
2009-10-23—Dimension Vista CHEM 3 calibrator is an in vitro diagnostic product for the calibration of ammonia
2009-10-22—Dimension Vista V-LYTE Fluids: Standard B/Salt Bridge catalog number K825
2009-10-22—Dimension Vista V-LYTE Fluids: Diluent catalog number K835
2009-10-22—Dimension Vista V-LYTE Fluids: Standard A catalog number K820
2009-10-21—IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150
2009-10-21—IMMULITE 2000 and IMMULITE 2500 IgG/IgM Sample Diluent, Cat. No. L2IGZ2, Lot Number 150
2009-09-01—Dimension Vista System StreamLAB Analytical Workcell. Dimension Vista System Part Numbers 1000035896
2009-08-31—Dimension Vista System CHEM 1 CAL, Catalog Number KC110, Lot Number 9DM001 The Dimension Vista CHEM
2009-07-14—EasyLink Informatics System included with the Dimension Vista System. The Dimension Vista Integrate
2009-06-16—Dimension Vista System BUN Flex Reagent Cartridge, Catalog number K1021, in vitro diagnostic.
2009-05-15—IMMULITE 2000/2500 Chemiluminescent Substrate Module For the use in the routine operation of the IM
2008-10-03—ADVIA Centaur Intact PTH (iPTH) Assay -assay (lot 138) Cat. Nos. 100 Test kit 04385983 (129501) 500
2008-04-28—Siemens Stratus CS Acute Care Troponin I CalPak. In vitro product intended to be used for calibrati
2008-04-15—Dimension Flex Reagent Cartridge C-Reactive Protein Extended Range (RCRP). In vitro diagnostic test
2008-04-08—Dimension Cardiac Troponin I Flex reagent cartridge (CTNI). The CTNI method for the Dimension Clin
2008-03-24—Dimension Total Prostate Specific Antigen (TPSA) Flex Reagent Cartridge (RF451). Siemens, Newark, DE
2007-03-02—Dimension Flex Reagent Cartridge Cardiac Tropinin-I, Catalog Number: RF421C and RF521. Intended to