ROCHE DIAGNOSTICS, INC

FDA Filings

This page includes the latest FDA filings for ROCHE 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
Roche Diagnostics Operations (RDO)
Tina-quant Hemoglobin A1cDx Gen.32020-03-26
Roche Diagnostics
Elecsys BRAHMS PCT2020-03-09
Roche Diagnostics
Elecsys Anti-TSHR2020-02-27
Roche Diagnostics Operations (RDO)
Tina-quant C-Reactive Protein IV2020-02-21
Roche Diagnostics
Glucose HK Gen.3, ISE Indirect Na For Gen.2, Elecsys TSH, Cobas Pro Integrated Solutions2019-08-16
Roche Diagnostics
Elecsys Anti-HAV II2019-08-13
Roche Diagnostics
Cobas U 601 Urinalysis Test System2019-05-07
Roche Diagnostics
Elecsys TSH2019-04-16
Roche Diagnostics Operations (RDO)
Ammonia II2019-02-08
Roche Diagnostics
Elecsys Tacrolimus2018-11-06
Roche Diagnostics Operations (RDO)
Tina-quant Transferrin Ver.2 (urine Application)2018-11-05
Roche Diagnostics
Elecsys FT4 III2018-09-18
Roche Diagnostics
Elecsys BRAHMS PCT2018-07-06
Roche Diagnostics
Elecsys CA 15-3 II2018-06-22
Roche Diagnostics
CoaguChek XS Plus System2018-04-19
Roche Diagnostics
CoaguChek XS Pro System2018-04-19
Roche Diagnostics Hematology, Inc.
Cobas M 511 Integrated Hematology Analyzer2018-03-02
Roche Diagnostics
Elecsys CA 15-3 II2018-02-20
Roche Diagnostics
CoaguChek Vantus System2017-12-25
Roche Diagnostics Operations
Cobas HbA1c Test, Cobas B 101 System2017-07-28
ROCHE DIAGNOSTICS
Elecsys Toxo IgM, Elecsys Toxo IgM PreciControl2017-06-23
ROCHE DIAGNOSTICS
Creatine Kinase-MB2017-05-26
Roche Diagnostics Operations (RDO)
ALP IFCC Gen.22017-05-10
Roche Diagnostics
Calset Igf-12017-04-26
Roche Diagnostics
Beta-CrossLaps CalCheck 52017-04-04
Roche Diagnostics
Elecsys CMV IgM2017-03-17
Roche Diagnostics
Elecsys Vitamin D Total II, Vitamin D Total II CalSet, PreciControl Vitamin D Total II, Vitamin D CalCheck 52017-02-08
ROCHE DIAGNOSTICS
Elecsys TSH Assay, Cobas E 801 Immunoassay Analyzer2017-01-23
Roche Diagnostics
Elecsys Troponin T Gen 5 STAT Assay, Elecsys Troponin T Gen 5 STAT CalSet, Elecsys PreciControl Troponin, Elecsys Troponin T Gen 5 CalCheck 52017-01-18
Roche Diagnostics
Elecsys CYFRA 21-1 CalCheck 52017-01-12

Latest Premarket Applications

PMAManufacturerDevice NameDate
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II, Elecsys HBsAg Confirmatory Test, and PreciControl HBsAg II2020-02-27
ROCHE DIAGNOSTICS CORP.
Elecsys total PSA Test System2019-05-03
ROCHE DIAGNOSTICS CORP.
Elecsys free PSA Test System2019-05-03
ROCHE DIAGNOSTICS CORP.
Elecsys HBsAg Immunoassay2019-04-24
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys Anti-HCV II2019-04-24
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II2019-04-24
ROCHE DIAGNOSTICS CORP.
Elecsys total PSA2019-04-24
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HBc IgM2019-04-24
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HBc IgM2019-04-24
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HBc IgM2019-04-24
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HBc II2019-04-24
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HBc II2019-04-24
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HCV Immunoassay2019-04-24
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HCV Immunoassay2019-04-24
ROCHE DIAGNOSTICS CORP.
Elecsys free PSA2019-04-24
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HCV Immunoassay2019-04-24
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HBs2019-04-24
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HBs; PreciControl Anti-HBs; Anti-HBs CalCheck2019-04-15
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HBc II2018-11-06
ROCHE DIAGNOSTICS CORP.
Elecsys ANti-HBs2018-11-06
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HBc II2018-11-06
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HBc IgM2018-11-06
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HBc IgM2018-11-06
ROCHE DIAGNOSTICS, INC.
Elecsys HBsAg II (100/200 tests)2018-11-06
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys HBeAg2018-11-06
ROCHE DIAGNOSTICS OPERATIONS INC
Elecsys ANti-HCV II (100/200 tests)2018-11-06
ROCHE DIAGNOSTICS CORP.
Elecsys Anti-HBc IgM2018-11-06
ROCHE DIAGNOSTICS CORP.
Elecsys free PSA Test System2018-10-25
ROCHE DIAGNOSTICS CORP.
Elecsys total PSA2018-10-25
ROCHE DIAGNOSTICS CORP.
Elecsys free PSA, free PSA CalSet, and free PSA CalCheck2018-07-27

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Elecsys HBsAg II
Roche Diagnostics GmbH2020-04-03
Elecsys HBsAg II
Roche Diagnostics GmbH2020-04-03
Elecsys HBsAg II
Roche Diagnostics GmbH2020-04-03
cobas pro B-Gate update Kit
Roche Diagnostics GmbH2020-03-30
Elecsys HBsAg Confirmatory Test
Roche Diagnostics GmbH2020-03-30
PreciControl HBsAg II
Roche Diagnostics GmbH2020-03-30
Tina-quant Lipoprotein (a) Gen.2
Roche Diagnostics GmbH2020-03-24
Tina-quant Apolipoprotein A-1 ver.2
Roche Diagnostics GmbH2020-03-24
Homocysteine Enzymatic Assay
Roche Diagnostics GmbH2020-03-24
Direct Bilirubin
Roche Diagnostics GmbH2020-03-23
Elecsys Cortisol CalCheck
Roche Diagnostics GmbH2020-03-23
Elecsys FSH
Roche Diagnostics GmbH2020-03-23
Elecsys LH
Roche Diagnostics GmbH2020-03-23
cobas pro Sample Buffer
Roche Diagnostics GmbH2020-03-18
cobas pro Sample Supply Unit
Roche Diagnostics GmbH2020-03-18
cobas pro c 503 SBL - DL
Roche Diagnostics GmbH2020-03-18
cobas pro c 503 SBL-TL
Roche Diagnostics GmbH2020-03-18
cobas pro e 801 SBL-DL
Roche Diagnostics GmbH2020-03-18
Gamma-Glutamyltransferase ver.2 Standardized against IFCC / Szasz
Roche Diagnostics GmbH2020-03-18
cobas pro ISE analytical unit
Roche Diagnostics GmbH2020-03-16
cobas c 503 analytical unit
Roche Diagnostics GmbH2020-03-16
ONLINE DAT Phencyclidine Plus
Roche Diagnostics GmbH2020-03-16
Cocaine
Roche Diagnostics GmbH2020-03-16
ONLINE DAT Benzodiazepines Plus
Roche Diagnostics GmbH2020-03-13
CalCheck Androstenedione
Roche Diagnostics GmbH2020-03-13
CalSet Androstenedione
Roche Diagnostics GmbH2020-03-13
Elecsys Androstenedione
Roche Diagnostics GmbH2020-03-13
Elecsys Androstenedione
Roche Diagnostics GmbH2020-03-13
ONLINE DAT Cannabinoids II
Roche Diagnostics GmbH2020-03-13
Propoxyphene Plus
Roche Diagnostics GmbH2020-03-13
ONLINE DAT Methaqualone
Roche Diagnostics GmbH2020-03-13
ONLINE DAT Lysergic Acid Diethylamide
Roche Diagnostics GmbH2020-03-13
PreciControl Maternal Care
Roche Diagnostics GmbH2020-03-13
Ethanol Gen.2
Roche Diagnostics GmbH2020-03-13
ONLINE TDM Vancomycin Gen.3
Roche Diagnostics GmbH2020-03-13

Related Finance Registrations

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.