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 System, Cobas Influenza A/b & Rsv Nucleic Acid Test For Use On The Cobas Liat System, Cobas Strep A Nucleic Acid Test For Use On The Cobas Liat System2020-02-10
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
Roche Molecular Systems, Inc.
Cobas Cdiff Nucleic Acid Test For Use On The Cobas Liat System2017-09-12
Roche Molecular Systems, Inc.
Cobas® CT/NG V2.0 Test2017-02-09
Roche Molecular Systems, Inc.
Automated Bloodborne Pathogen Test Equipment2016-10-20
Roche Molecular Systems, Inc.
Automated Bloodborne Pathogen Test Equipment2016-10-20
ROCHE MOLECULAR SYSTEMS, INC.
Cobas HSV 1 And 2 Test2015-06-01
ROCHE MOLECULAR SYSTEMS, INC.
Cobas Cdiff Test2015-05-20
ROCHE MOLECULAR SYSTEMS, INC.
Cobas MRSA/SA Test2014-12-17
ROCHE MOLECULAR SYSTEMS, INC.
COBAS CT/NG V2.0 TEST2014-05-05
ROCHE MOLECULAR SYSTEMS, INC.
COBAS CT/NG V2.0 TEST2013-12-02
ROCHE MOLECULAR SYSTEMS, INC.
COBAS 4800 CT / NG TEST2012-01-24
ROCHE MOLECULAR SYSTEMS, INC.
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 052057272010-07-06
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE AMPLICHIP CYP450 TEST2005-01-10
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE COBAS TAQMAN ANALYZER2002-02-01
ROCHE MOLECULAR SYSTEMS, INC.
Roche Amplicor Ct/ng Test For Neisseria Gonorrhoeae1999-12-01
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS1999-08-04
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE1999-05-28
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS1998-12-15
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST1997-06-13
ROCHE MOLECULAR SYSTEMS, INC.
ROCHE COBAS AMPLICOR ANALYZER1997-05-21
ROCHE MOLECULAR SYSTEMS, INC.
AMPLICOR CHLAMYDIA TRACHOMATIS TEST1993-06-15

Latest Premarket Applications

PMAManufacturerDevice NameDate
Roche Molecular Systems, Inc.
cobas HCV2020-02-06
ROCHE MOLECULAR SYSTEMS, INC.
cobas CMV2020-02-06
Roche Molecular Systems, Inc.
cobas HBV2020-02-06
Roche Molecular Systems, Inc.
COBAS HCV TEST2019-12-18
Roche Molecular Systems, Inc.
COBAS HBV TEST2019-12-18
ROCHE MOLECULAR SYSTEMS, INC.
COBAS CMV TEST2019-12-18
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan HCV Test v2.02019-11-05
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan HBV Test, v2.02019-11-05
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan CMV Test2019-11-05
ROCHE MOLECULAR SYSTEMS, INC.
cobas CMV Test2019-10-10
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 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 AmpliPrep and Cobas TaqMan CMV 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 HPV Test2019-10-10
Roche Molecular Systems, Inc.
cobas BRAF V600 Mutation Test2019-10-10
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 HBV Test, v2.02019-09-12
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan HCV Test V2.02019-09-12
Roche Molecular Systems, Inc.
COBAS AmpliPrep/COBAS TaqMan CMV Test2019-09-12
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 CMV Test2019-08-13

Latest De Novo Filings

De NovoManufacturerDevice NameDate
Roche Molecular Systems, Inc.
Cobas VivoDx MRSA2019-12-05

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
cobas® vivoDx System
Roche Molecular Systems, Inc.2020-01-23
cobas® vivoDx MRSA
Roche Molecular Systems, Inc.2020-01-23
cobas® vivoDx MRSA Control Media
Roche Molecular Systems, Inc.2020-01-23
cobas® vivoDx MRSA Collection and Transport Kit
Roche Molecular Systems, Inc.2020-01-23
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

Related Finance Registrations

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