Roche Molecular Systems, Inc.
FDA 510(k) medical device clearances.
Top product codes for Roche Molecular Systems, Inc.
Recent clearances by Roche Molecular Systems, Inc.
- K243753 — cobas liat Bordetella panel nucleic acid test
- K252481 — cobas CMV
- K252484 — cobas HCV
- K243455 — cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems
- K243863 — Opulus Lymphoma Precision
- K243400 — cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test
- K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
- K243346 — cobas liat SARS-CoV-2 v2 nucleic acid test
- K240867 — cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems
- K240217 — cobas® liat CT/NG nucleic acid test
- K240197 — cobas® liat CT/NG/MG nucleic acid test
- K223783 — cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System
- K223591 — cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas® Liat® System
- K231306 — cobas SARS-CoV-2 Qualitative for use on the cobas 5800/6800/8800 Systems
- K221007 — cobas HCV
- K213804 — cobas SARS-CoV-2 Qualitative for use on the cobas 6800/8800 Systems
- K213822 — cobas Influenza A/B & RSV nucleic acid test for use on the cobas Liat System
- K212427 — cobas Cdiff nucleic acid test for use on the cobas Liat System
- K210385 — cobas Cdiff nucleic acid test for use on the cobas Liat System
- K210234 — cobas Influenza A/B & RSV Nucleic acid test for use on the cobas Liat System
- K203220 — cobas BKV
- K202408 — cobas CTNG for use on cobas 6800/8800 systems
- K202215 — cobas BKV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
- DEN200015 — cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit
- K200065 — 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
- DEN190016 — cobas vivoDx MRSA
- K191729 — Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System
- K190433 — cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit
- K173887 — cobas CT/NG for use on cobas 6800/8800 systems
- K172913 — cobas Factor II and Factor V Test
- K171770 — cobas Cdiff Nucleic acid test for use on the cobas Liat System
- K163184 — cobas® CT/NG v2.0 Test
- K150617 — cobas HSV 1 and 2 Test
- K142422 — cobas Cdiff Test
- K142721 — cobas MRSA/SA Test
- K140887 — COBAS CT/NG V2.0 TEST
- K132270 — COBAS CT/NG V2.0 TEST
- K110923 — COBAS 4800 CT / NG TEST
- K091409 — LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727
- K043576 — ROCHE AMPLICHIP CYP450 TEST
- DEN040011 — AMPLICHIP CYP450 TEST, MODEL 04381866190
- K012966 — ROCHE COBAS TAQMAN ANALYZER
- K974503 — ROCHE AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
- K973707 — ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
- K974342 — ROCHE COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
- K973718 — ROCHE COBAS AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
- K964507 — ROCHE COBAS AMPLICOR CHLAMYDIA TRACHOMATIS TEST
- K964506 — ROCHE COBAS AMPLICOR ANALYZER
- K922906 — AMPLICOR CHLAMYDIA TRACHOMATIS TEST
Data sourced from openFDA. This site is unofficial and independent of the FDA.