SIEMENS HEALTHCARE DIAGNOSTICS

FDA Filings

This page includes the latest FDA filings for SIEMENS HEALTHCARE DIAGNOSTICS. 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.
RAPIDPoint 500e Blood Gas System2020-03-27
Siemens Healthcare Diagnostics Inc.
ADVIA Centaur BR2020-02-13
Siemens Healthcare Diagnostics Inc.
ADVIA Centaur Total IgE (tIgE)2020-01-15
Siemens Healthcare Diagnostics, Inc.
ADVIA Centaur Cortisol (COR)2019-11-25
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
N Latex FLC Kappa Assay, N Latex FLC Lambda Assay2018-11-01
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 Products GmbH
Sysmex CS-51002017-10-31
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

Latest Premarket Applications

PMAManufacturerDevice NameDate
SIEMENS HEALTHCARE DIAGNOSTICS INC.
ADVIA Centaur and Atellica IM AFP2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS INC.
ADVIA Centaur and Atellica IM Anti-HBs2 (aHBs2)2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM cPSA2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM PSA2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM HBeAg2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM HBc Total2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur HBsAg2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM HBc IgM2020-03-19
SIEMENS HEALTHCARE DIAGNOSTICS
ADVIA Centaur and Atellica IM HCV2020-03-19
Siemens Healthcare Diagnostics Products, LTD
IMMULITE 2000 HBsAg & HBs Ag Confirmatory2019-12-19
Siemens Healthcare Diagnostics Products, LTD
IMMULITE 2000 Anti HBc IgM2019-12-19
Siemens Healthcare Diagnostics Products, LTD
IMMULITE 2000 Anti-HBs2019-12-19
Siemens Healthcare Diagnostics Products, LTD
IMMULITE 2000 Anti-HBc2019-12-19
SIEMENS HEALTHCARE DIAGNOSTICS INC.
IMMULITE 2000 PSA2019-12-19
SIEMENS HEALTHCARE DIAGNOSTICS INC.
IMMULITE 2000 AFP2019-12-19
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
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 Complexed PSA (cPSA) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis C (aHCV) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B e Antigen (HBeAg) Assay2019-03-08
SIEMENS HEALTHCARE DIAGNOSTICS
Atellica IM Hepatitis B orfe IgM (aHBcM) Assay2019-03-08

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Atellica CH UCFP
Siemens Healthcare Diagnostics Inc.2020-03-17
Atellica CH UCFP Calibrator
Siemens Healthcare Diagnostics Inc.2020-03-17
ADVIA Chemistry UCFP Calibrator
Siemens Healthcare Diagnostics Inc.2020-03-16
ADVIA Chemistry UCFP
Siemens Healthcare Diagnostics Inc.2020-03-16
Atellica IM Zika Ab QC
Siemens Healthcare Diagnostics Inc.2020-03-03
Atellica IM Zika Ab 100T
Siemens Healthcare Diagnostics Inc.2020-03-03
Atellica IM Zika IgM Controls
Siemens Healthcare Diagnostics Inc.2020-03-03
Atellica IM Zika IgM 50T
Siemens Healthcare Diagnostics Inc.2020-03-03
ADVIA Centaur Zika Ab QC
Siemens Healthcare Diagnostics Inc.2020-03-03
ADVIA Centaur Zika Ab 100T
Siemens Healthcare Diagnostics Inc.2020-03-03
ADVIA Centaur Zika IgM QC
Siemens Healthcare Diagnostics Inc.2020-03-03
ADVIA Centaur Zika IgM 50T
Siemens Healthcare Diagnostics Inc.2020-03-03
N Rheumatology Standard SL
Siemens Healthcare Diagnostics Products GmbH2020-02-24
ADVIA Centaur® PSA
Siemens Healthcare Diagnostics Inc.2020-02-06
ADVIA Centaur® PSA
Siemens Healthcare Diagnostics Inc.2020-02-06
ADVIA Centaur® Systems, ACS 180® Systems PSA MCM
Siemens Healthcare Diagnostics Inc.2020-02-06
ADVIA Centaur® Systems. ACS:180® Systems Calibrator Q
Siemens Healthcare Diagnostics Inc.2020-02-06
ADVIA Centaur® Systems, ACS:180® Systems Calibrator Q
Siemens Healthcare Diagnostics Inc.2020-02-06
IMMULITE®Systems sPS CONTROL Third Generation PSA
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD2020-02-06
Dimension® clinical chemistry system FPSA Flex® reagent cartridge
Siemens Healthcare Diagnostics Inc.2020-02-06
IMMULITE®/IMMULITE®1000 Systems 3PS Third Generation PSA
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD2020-02-06
Dimension® clinical chemistry system TPSA Flex® reagent cartridge
Siemens Healthcare Diagnostics Inc.2020-02-06
IMMULITE® 2000 Systems PTS PSA
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD2020-02-06
IMMULITE® 2000 Systems PTS PSA
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD2020-02-06
IMMULITE®/IMMULITE®1000 Systems PTS PSA
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD2020-02-06
Atellica IM PSA MCM
Siemens Healthcare Diagnostics Inc.2020-02-06
Atellica IM PSA
Siemens Healthcare Diagnostics Inc.2020-02-06
Atellica IM PSA
Siemens Healthcare Diagnostics Inc.2020-02-06
IMMULITE® 2000 Systems fPS Free PSA
SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS LTD2020-02-06
Atellica IM cPSA QC
Siemens Healthcare Diagnostics Inc.2020-02-06
Atellica IM cPSA PRE
Siemens Healthcare Diagnostics Inc.2020-02-06
Atellica IM cPSA MCM
Siemens Healthcare Diagnostics Inc.2020-02-06
Atellica IM cPSA
Siemens Healthcare Diagnostics Inc.2020-02-06
Atellica IM Calibrator Y
Siemens Healthcare Diagnostics Inc.2020-02-06
Atellica IM Calibrator Q
Siemens Healthcare Diagnostics Inc.2020-02-06

Related Finance Registrations
Legal Entity Identifier 52990015XR7SMX5HGL68 [SIEMENS HEALTHCARE DIAGNOSTICS]
Legal Entity Identifier 52990057ZS50R2R3PR06 [Siemens Healthcare Diagnostics GmbH]
Legal Entity Identifier 52990086OD9IUZOLZQ17 [Siemens Healthcare Diagnostics GmbH]
Legal Entity Identifier 529900GHH6JCS5O81B46 [Siemens Healthcare Diagnostics GmbH]
Legal Entity Identifier 549300CGX74JSH7OWU22 [SIEMENS HEALTHCARE DIAGNOSTICS INC.]

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