Siemens Healthcare Diagnostics, Inc

FDA Filings

This page includes the latest FDA filings for Siemens Healthcare Diagnostics, Inc. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur CA 15-3 Assay2019-11-22
Siemens Healthcare Diagnostics Inc.
Atellica IM Total HCG (ThCG)2019-10-30
Siemens Healthcare Diagnostics Inc.
ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG2019-08-28
Siemens Healthcare Diagnostics Inc.
Atellica CH Amylase_2 (AMY_2)2019-07-30
Siemens Healthcare Diagnostics Inc.
ADVIA Centaur Zika Test, ADVIA Centaur Zika Ab (100 Tests), ADVIA Centaur Zika IgM (50 Tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control2019-07-17
Siemens Healthcare Diagnostics, Inc.
Dimension EXL High-Sensitivity Troponin I (TNIH) Assay2019-05-17
Siemens Healthcare Diagnostics Products GmbH
N Latex FLC Kappa, N Latex FLC Lambda2019-05-03
Siemens Healthcare Diagnostics, Inc.
Dimension Vista High-Sensitivity Troponin I (TNIH) Assay2019-03-04
Siemens Healthcare Diagnostics Products GmbH
INNOVANCE Free PS Ag2018-09-07
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur CMV IgG And ADVIA Centaur CMV IgG Quality Control2018-07-30
Siemens Healthcare Diagnostics Inc.
Atellica IM High-Sensitivity Troponin I (TNIH)2018-07-19
Siemens Healthcare Diagnostics Inc.
Atellica IM BRAHMS Procalcitonin (PCT)2018-07-16
Siemens Healthcare Diagnostics Inc.
Dimension Hemoglobin A1c Assay2018-07-13
Siemens Healthcare Diagnostics Inc.
ADVIA Centaur High-Sensitivity Troponin I (TNIH)2018-07-12
Siemens Healthcare Diagnostics, Inc.
ADVIA Chemistry Cystatin C_2 Assay (CYSC_2)2018-05-25
Siemens Healthcare Diagnostics Inc.
Atellica IM Folate Assay2018-04-12
Siemens Healthcare Diagnostics Inc.
Atellica IM Total HCG (ThCG)2018-03-29
Siemens Healthcare Diagnostics Inc.
ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay2017-12-04
Siemens Healthcare Diagnostics Products GmbH
N Latex FLC Kappa Assay, N Latex FLC Lambda Assay, N FLC Standard SL, N FLC Control SL1 & SL22017-11-17
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Emit II Plus Cocaine Metabolite Assay2017-10-25
Siemens Healthcare Diagnostics Inc.
Emit II Plus Oxycodone Assay2017-10-18
Siemens Healthcare Diagnostics Inc.
Atellica IM Ferritin Assay2017-08-31
SIEMENS HEALTHCARE DIAGNOSTICS PRODCTS GMBH
INNOVANCE(r) Heparin Reagents, INNOVANCE(r) Heparin Calibrator, INNOVANCE(r) Heparin UF And Heparin LMW Controls2017-08-22
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA 2120i, ADVIA 21202017-08-11
Siemens Healthcare Diagnostics Inc.
ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay2017-05-23
Siemens Healthcare Diagnostics Products GmbH
N Latex Cystatin C; N Protein Standard UY2017-05-12
Siemens Healthcare Diagnostics Products GmbH
Sysmex CS-2100i2016-12-26
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH
Sysmex Automated Blood Coagulation Analyzer CS-51002016-12-12
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator2016-11-17
Siemens Healthcare Diagnostics, Inc.
Atellica CH Creatinine_2 (Crea_2), Atellica CH Chemistry Calibrator (CHEM CAL)2016-11-15

Latest Premarket Applications

PMAManufacturerDevice NameDate
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBsAg2019-10-25
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
Versant HCV Genotype 2.0 Assay (LiPA)2019-09-20
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur PSA, ADVIA Centaur CP PSA and Atellica IM PSA2019-07-25
SIEMENS HEALTHCARE DIAGNOSTICS INC.
IMMULITE Systems PSA, IMMULITE 2000 Systems PSA & IMMULITE Systems Third Generation PSA2019-07-11
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge (K6452)2019-06-26
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge (K6451)2019-06-26
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension FPSA Flex reagent cartridge2019-06-20
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension TPSA Flex reagent cartridge2019-06-20
SIEMENS HEALTHCARE DIAGNOSTICS, INC.
VERSANT HCV Genotype 2.0 Assay (LiPA)2019-04-05
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Atellica IM Alpha Fetoprotein (AFP) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Complexed PSA (cPSA) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Atellica IM Anti-Hepatitis B surface Antigen 2 (aHBs2) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B e Antigen (HBeAg) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis C (aHCV) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica Im Anti-Hepatitis B core Total (HBcT) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Prostate-Specific Antigen (PSA) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B orfe IgM (aHBcM) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Atellica IM Alpha Fetoprotein (AFP)2019-03-07
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista TPSA Flex reagent cartridge2018-12-27
SIEMENS HEALTHCARE DIAGNOSTICS INC.
IMMULITE/IMMULITE 1000 AFP and IMMULITE 2000 AFP2018-12-27
SIEMENS HEALTHCARE DIAGNOSTICS
Dimension Vista FPSA Flex reagent cartridge2018-12-27
SIEMENS HEALTHCARE DIAGNOSTICS INC.
IMMULITE/IMMULITE 1000 PSA and IMMULITE 2000 PSA AND 1000 Third Generation PSA2018-12-27
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Atellica IM Alpha Fetoprotein (AFP)2018-10-25
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Prostate-Specific Antigen (PSA)2018-10-25
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Complexed PSA (cPSA)2018-10-25
SIEMENS HEALTHCARE DIAGNOSTICS INC.
Atellica IM Anti-Hepatitis B Surface Antigen 2 (aHBs2)2018-09-11
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B core IgM (aHBcM)2018-09-11
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Analyzer Hepatitis C (aHCV)2018-09-11
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM anti-HBc Total (HBcT)2018-09-11
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B e Antigen (HBeAg)2018-09-11

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Atellica IM EPO QC
Siemens Healthcare Diagnostics Inc.2019-11-26
Atellica IM EPO MCM
Siemens Healthcare Diagnostics Inc.2019-11-26
Atellica IM EPO
Siemens Healthcare Diagnostics Inc.2019-11-26
ADVIA Centaur EPO Quality Control
Siemens Healthcare Diagnostics Inc.2019-11-26
ADVIA Centaur EPO MCM
Siemens Healthcare Diagnostics Inc.2019-11-26
ADVIA Centaur EPO
Siemens Healthcare Diagnostics Inc.2019-11-26
Syva Emit II Plus 6-Acetylmorphine Assay
Siemens Healthcare Diagnostics Inc.2019-11-25
ADVIA Centaur® Zika IgM Assay 50T
Siemens Healthcare Diagnostics Inc.2019-11-15
ADVIA Centaur® Systems aHBs QC
Siemens Healthcare Diagnostics Inc.2019-11-15
Atellica CH Cystatin C_2 Calibrators
Siemens Healthcare Diagnostics Inc.2019-11-15
ADVIA Centaur® PTH
Siemens Healthcare Diagnostics Inc.2019-11-12
ADVIA Centaur® Zika Ab Assay 100T
Siemens Healthcare Diagnostics Inc.2019-11-12
ADVIA Centaur Androstenedione kit
Siemens Healthcare Diagnostics Inc.2019-11-04
ADVIA Centaur Androstenedione MCM
Siemens Healthcare Diagnostics Inc.2019-11-04
Dimension EXL TNIH Calibrator
Siemens Healthcare Diagnostics Inc.2019-10-24
Dimension EXL LOCI Troponin I High Sensitive
Siemens Healthcare Diagnostics Inc.2019-10-24
Atellica IM EHIV
Siemens Healthcare Diagnostics Inc.2019-10-23
Atellica™ IM aHBs2
Siemens Healthcare Diagnostics Inc.2019-10-23
ADVIA® Chemistry P5P_c Pyridoxal-5-Phosphate Reagents
Siemens Healthcare Diagnostics Inc.2019-10-23
Hemastix® Reagent Strips
Siemens Healthcare Diagnostics Inc.2019-10-07
ADVIA Centaur® PSA
Siemens Healthcare Diagnostics Inc.2019-10-04
Atellica IM PSA
Siemens Healthcare Diagnostics Inc.2019-10-04
ADVIA Centaur® Zika IgM Quality Control
Siemens Healthcare Diagnostics Inc.2019-10-02
ADVIA Centaur® Zika Ab Quality Control
Siemens Healthcare Diagnostics Inc.2019-10-02
Atellica™ IM aHBs2 MCM
Siemens Healthcare Diagnostics Inc.2019-09-30
Atellica IM CHIV
Siemens Healthcare Diagnostics Inc.2019-09-30
Atellica™ IM ThCG MCM
Siemens Healthcare Diagnostics Inc.2019-09-30
Atellica™ IM ThCG DIL
Siemens Healthcare Diagnostics Inc.2019-09-30
Atellica™ IM ThCG DIL
Siemens Healthcare Diagnostics Inc.2019-09-30
Atellica™ IM ThCG DIL
Siemens Healthcare Diagnostics Inc.2019-09-30
Atellica™ IM ThCG
Siemens Healthcare Diagnostics Inc.2019-09-30
Atellica™ IM ThCG
Siemens Healthcare Diagnostics Inc.2019-09-30
Atellica IM PSA MCM
Siemens Healthcare Diagnostics Inc.2019-09-30
Atellica IM PSA
Siemens Healthcare Diagnostics Inc.2019-09-30
Atellica™ IM HBsII QC
Siemens Healthcare Diagnostics Inc.2019-09-30

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