Roche Molecular Systems, Inc. - FDA 510(k) Cleared Devices

Cleared Nov 20, 2025

cobas liat Bordetella panel nucleic acid test

K243753 · OZZ

Microbiology · 350d

Cleared Nov 03, 2025

cobas CMV

K252481 · PAB

Microbiology · 88d

Cleared Nov 03, 2025

cobas HCV

K252484 · MZP

Microbiology · 88d

Cleared Jul 31, 2025

cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 Systems

K243455 · QOF

Microbiology · 266d

Cleared Apr 25, 2025

cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test

K243400 · QOF

Microbiology · 176d

Cleared Apr 25, 2025

cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test

K243406 · QOF

Microbiology · 175d

Cleared Apr 11, 2025

cobas liat SARS-CoV-2 v2 nucleic acid test

K243346 · QWR

Microbiology · 165d

Cleared Feb 11, 2025

cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 Systems

K240867 · QQX

Microbiology · 319d

Cleared Jan 17, 2025

cobas® liat CT/NG nucleic acid test

K240217 · QEP

Microbiology · 357d

Cleared Jan 16, 2025

cobas® liat CT/NG/MG nucleic acid test

K240197 · QEP

Microbiology · 357d

Cleared Dec 04, 2023

cobas SARS-CoV-2 Nucleic acid test for use on the cobas Liat System

K223783 · QWR

Microbiology · 353d

Cleared Jul 27, 2023

cobas® SARS-CoV-2 & Influenza A/B Nucleic acid test for use on the cobas®...

K223591 · QOF

Microbiology · 238d