Roche Molecular Systems, Inc

FDA Filings

This page includes the latest FDA filings for Roche Molecular Systems, 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 Molecular Systems, Inc.
Cobas Influenza A/B Nucleic Acid Test For Use On The Cobas Liat System2019-07-24
Roche Molecular Systems, Inc.
Cobas TV/MG For Use On Cobas 6800/8800 Systems, Cobas TV/MG Positive Control Kit, Cobas Buffer Negative Control Kit2019-05-22
Roche Molecular Systems, Inc.
Cobas CT/NG For Use On Cobas 6800/8800 Systems2018-03-21
Roche Molecular Systems, Inc.
Cobas Factor II And Factor V Test2018-01-12

Latest Premarket Applications

PMAManufacturerDevice NameDate
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan HCV Test v2.02019-11-05
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan CMV Test2019-11-05
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.02019-11-05
Roche Molecular Systems, Inc.
cobas HPV Test2019-10-10
Roche Molecular Systems, Inc.
cobas HBV Test2019-10-10
Roche Molecular Systems, Inc.
cobas HCV Test2019-10-10
Roche Molecular Systems, Inc.
cobas BRAF V600 Mutation Test2019-10-10
Roche Molecular Systems, Inc.
Cobas AmpliPrep and Cobas TaqMan CMV Test2019-10-10
ROCHE MOLECULAR SYSTEMS, INC.
cobas CMV Test2019-10-10
Roche Molecular Systems, Inc.
Cobas TaqMan HCV Test, v2.0, for Use with the High Pure System and Cobas AmpliPrep, Cobas TaqMan HCV Test, v2.02019-10-10
Roche Molecular Systems, Inc.
cobas KRAS Mutation Test2019-10-10
Roche Molecular Systems, Inc.
Cobas TaqMan HBV Test for Use with the High Pure System and Cobas AmpliPrep, CobasTaqMan HBV Test, v2.02019-10-10
Roche Molecular Systems, Inc.
cobas HBV2019-09-26
ROCHE MOLECULAR SYSTEMS, INC.
cobas CMV2019-09-26
Roche Molecular Systems, Inc.
cobas HCV2019-09-26
Roche Molecular Systems, Inc.
cobas 4800 BRAF V600 Mutation Test2019-09-25
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan CMV Test2019-09-12
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan HCV Test V2.02019-09-12
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.02019-09-12
Roche Molecular Systems, Inc.
cobas HBV Test2019-09-04
ROCHE MOLECULAR SYSTEMS, INC.
Cobas CMV2019-09-04
Roche Molecular Systems, Inc.
cobas HCV2019-09-04
Roche Molecular Systems, Inc.
cobas HPV2019-09-03
Roche Molecular Systems, Inc.
cobas AmpliPrep/cobas TaqMan HCV Test, v22019-08-13
Roche Molecular Systems, Inc.
cobas AmpliPrep/cobas TaqMan CMV Test2019-08-13
Roche Molecular Systems, Inc.
cobas AmpliPrep/cobas TaqMan HBV Test, v22019-08-13
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan HCV Test v2.02019-06-13
Roche Molecular Systems, Inc.
Cobas HCV2019-06-06
ROCHE MOLECULAR SYSTEMS, INC.
Cobas CMV2019-06-06
Roche Molecular Systems, Inc.
Cobas HCV2019-06-06

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
LightCycler¿ MRSA Advanced Test¿
Roche Molecular Systems, Inc.2019-01-23
cobas Factor II and Factor V Test
Roche Molecular Systems, Inc.2018-07-06
cobas CTNG Positive Control Kit
Roche Molecular Systems, Inc.2018-05-28
cobas CTNG Qualitative nucleic acid test for use o
Roche Molecular Systems, Inc.2018-05-28
cobas Liat Analyzer Software 3.2
Roche Molecular Systems, Inc.2018-04-16
cobas Liat Software Version 3.0
Roche Molecular Systems, Inc.2018-04-02
cobas® Influenza A/B & RSV Nucleic acid test for u
Roche Molecular Systems, Inc.2018-03-29
cobas PCR Media Dual Swab Sample Kit
Roche Molecular Systems, Inc.2018-03-29
cobas® PCR Media Uni Swab Sample Kit
Roche Molecular Systems, Inc.2018-03-29
cobas Liat Cleaning Tool
Roche Molecular Systems, Inc.2018-03-29
cobas® Influenza A/B &RSV Quality Control Kit for
Roche Molecular Systems, Inc.2018-03-29
cobas® Strep A Quality Control Kit for use on the
Roche Molecular Systems, Inc.2018-03-29
cobas® Influenza A/B Quality Control Kit for use o
Roche Molecular Systems, Inc.2018-03-29
cobas® Strep A Nucleic acid test for use on the co
Roche Molecular Systems, Inc.2018-03-29
cobas® Influenza A/B Nucleic acid test for use on
Roche Molecular Systems, Inc.2018-03-29
cobas¿ EGFR Mutation Test v2
Roche Molecular Systems, Inc.2018-03-29
cobas¿ cfDNA Sample Preparation Kit
Roche Molecular Systems, Inc.2018-03-29
cobas¿ 4800 CTNG Test v20
Roche Molecular Systems, Inc.2018-03-29
cobas¿ 4800 CTNG Test v20
Roche Molecular Systems, Inc.2018-03-29
cobas® 4800 System Lysis Kit
Roche Molecular Systems, Inc.2018-03-29
cobas CMV Control Kit
Roche Molecular Systems, Inc.2018-03-29
cobas CMV
Roche Molecular Systems, Inc.2018-03-29
cobas® 4800 Systems Internal Control Kit
Roche Molecular Systems, Inc.2018-03-29
cobas¿ MRSASA Controls and Cofactor Kit
Roche Molecular Systems, Inc.2018-03-29
cobas® 4800 System Lysis Kit
Roche Molecular Systems, Inc.2018-03-29
cobas¿ MRSASA Test¿
Roche Molecular Systems, Inc.2018-03-29
cobas¿ MRSASA Test¿
Roche Molecular Systems, Inc.2018-03-29
cobas® EGFR Mutation Test
Roche Molecular Systems, Inc.2018-03-29
cobas¿ KRAS Mutation Test
Roche Molecular Systems, Inc.2018-03-29
COBAS® TaqMan® HCV Test For Use With the High Pure
Roche Molecular Systems, Inc.2018-03-29
cobas® 4800 BRAF V600 Mutation Test
Roche Molecular Systems, Inc.2018-03-29
cobas® DNA Sample Preparation Kit
Roche Molecular Systems, Inc.2018-03-29
COBAS® TaqMan® HIV-1 Test version 2.0, For Use Wit
Roche Molecular Systems, Inc.2018-03-29
cobas¿ TaqScreen MPX Test, v2.0
Roche Molecular Systems, Inc.2018-03-29
cobas¿ TaqScreen MPX Control Kit, v2.0
Roche Molecular Systems, Inc.2018-03-29

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