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Roche Molecular Systems, Inc.

53 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
cobas® BV/CV (K260021)Roche Molecular Systems, Inc.2026-07-16
cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems (K260917)Roche Molecular Systems, Inc.2026-07-08
cobas liat CT/NG/MG nucleic acid test (K253759)Roche Molecular Systems, Inc.2026-05-15
cobas liat CT/NG nucleic acid test (K253756)Roche Molecular Systems, Inc.2026-05-15
cobas liat Bordetella panel nucleic acid test (K243753)Roche Molecular Systems, Inc.2025-11-20
cobas CMV (K252481)Roche Molecular Systems, Inc.2025-11-03
cobas HCV (K252484)Roche Molecular Systems, Inc.2025-11-03
cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems (K243455)Roche Molecular Systems, Inc.2025-07-31
Opulus™ Lymphoma Precision (K243863)Roche Molecular Systems, Inc.2025-05-30
cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test (K243406)Roche Molecular Systems, Inc.2025-04-25
cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test (K243400)Roche Molecular Systems, Inc.2025-04-25
cobas liat SARS-CoV-2 v2 nucleic acid test (K243346)Roche Molecular Systems, Inc.2025-04-11
cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems (K240867)Roche Molecular Systems, Inc.2025-02-11
cobas® liat CT/NG nucleic acid test (K240217)Roche Molecular Systems, Inc.2025-01-17
cobas® liat CT/NG/MG nucleic acid test (K240197)Roche Molecular Systems, Inc.2025-01-16
cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System (K223783)Roche Molecular Systems, Inc.2023-12-04
cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System (K223591)Roche Molecular Systems, Inc.2023-07-27
cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems (K231306)Roche Molecular Systems, Inc.2023-06-01
cobas HCV (K221007)Roche Molecular Systems, Inc.2022-11-04
cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems (K213804)Roche Molecular Systems, Inc.2022-10-22
cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System (K213822)Roche Molecular Systems, Inc.2022-07-06
cobas Cdiff nucleic acid test for use on the cobas Liat System (K212427)Roche Molecular Systems, Inc.2021-10-20
cobas Cdiff nucleic acid test for use on the cobas Liat System (K210385)Roche Molecular Systems, Inc.2021-09-09
cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System (K210234)Roche Molecular Systems, Inc.2021-02-16
cobas BKV (K203220)Roche Molecular Systems, Inc.2021-01-29
cobas CTNG for use on cobas 6800/8800 systems (K202408)Roche Molecular Systems, Inc.2021-01-21
cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (K202215)Roche Molecular Systems, Inc.2020-09-02
cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit (DEN200015)Roche Molecular Systems, Inc.2020-07-30
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 System (K200065)Roche Molecular Systems, Inc.2020-02-10
cobas vivoDx MRSA (DEN190016)Roche Molecular Systems, Inc.2019-12-05
Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System (K191729)Roche Molecular Systems, Inc.2019-07-24
cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit (K190433)Roche Molecular Systems, Inc.2019-05-22
cobas CT/NG for use on cobas 6800/8800 systems (K173887)Roche Molecular Systems, Inc.2018-03-21
cobas Factor II and Factor V Test (K172913)Roche Molecular Systems, Inc.2018-01-12
cobas Cdiff Nucleic acid test for use on the cobas Liat System (K171770)Roche Molecular Systems, Inc.2017-09-12
cobas® CT/NG v2.0 Test (K163184)Roche Molecular Systems, Inc.2017-02-09
cobas HSV 1 and 2 Test (K150617)Roche Molecular Systems, Inc.2015-06-01
cobas Cdiff Test (K142422)Roche Molecular Systems, Inc.2015-05-20
cobas MRSA/SA Test (K142721)Roche Molecular Systems, Inc.2014-12-17
COBAS CT/NG V2.0 TEST (K140887)Roche Molecular Systems, Inc.2014-05-05
COBAS CT/NG V2.0 TEST (K132270)Roche Molecular Systems, Inc.2013-12-02
COBAS 4800 CT / NG TEST (K110923)Roche Molecular Systems, Inc.2012-01-24
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 (K091409)Roche Molecular Systems, Inc.2010-07-06
ROCHE AMPLICHIP CYP450 TEST (K043576)Roche Molecular Systems, Inc.2005-01-10
AMPLICHIP CYP450 TEST, MODEL 04381866190 (DEN040011)Roche Molecular Systems, Inc.2004-12-23
ROCHE COBAS TAQMAN ANALYZER (K012966)Roche Molecular Systems, Inc.2002-02-01
ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K974503)Roche Molecular Systems, Inc.1999-12-01
ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K973707)Roche Molecular Systems, Inc.1999-08-04
ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE (K974342)Roche Molecular Systems, Inc.1999-05-28
ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS (K973718)Roche Molecular Systems, Inc.1998-12-15
ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST (K964507)Roche Molecular Systems, Inc.1997-06-13
ROCHE COBAS AMPLICOR ANALYZER (K964506)Roche Molecular Systems, Inc.1997-05-21
AMPLICOR CHLAMYDIA TRACHOMATIS TEST (K922906)Roche Molecular Systems, Inc.1993-06-15

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Every clearance here is in the API, with alerts when new ones post.