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Roche Molecular Systems, Inc.

FDA 510(k) & PMA Approved Devices — 47 products

Total Devices47
Categories18
Latest FDA decision2026-07-16
TypeNumberDevice NameCodeDateActions
510(k) K260021 cobas® BV/CVPQA2026-07-16 View
510(k) K260917 cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systemsQEP2026-07-08 View
PMA P190028 KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSMAQ2026-06-16 View
510(k) K253756 cobas liat CT/NG nucleic acid testQEP2026-05-15 View
510(k) K253759 cobas liat CT/NG/MG nucleic acid testQEP2026-05-15 View
PMA P110020 Somatic gene mutation detection systemOWD2026-03-17 View
PMA P140023 Somatic gene mutation detection systemOWD2026-03-17 View
PMA P100020 KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUSMAQ2026-03-17 View
510(k) K243753 cobas liat Bordetella panel nucleic acid testOZZ2025-11-20 View
510(k) K252484 cobas HCVMZP2025-11-03 View
510(k) K252481 cobas CMVPAB2025-11-03 View
PMA P150014 Hepatitis Viral B DNA DetectionMKT2025-10-17 View
510(k) K243455 cobas Respiratory 4-flex for use on the cobas 5800/6800/8800 SystemsQOF2025-07-31 View
510(k) K243863 Opulus™ Lymphoma PrecisionQIH2025-05-30 View
510(k) K243400 cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid testQOF2025-04-25 View
510(k) K243406 cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid testQOF2025-04-25 View
510(k) K243346 cobas liat SARS-CoV-2 v2 nucleic acid testQWR2025-04-11 View
510(k) K240867 cobas® SARS-CoV-2 Qualitative for use on the cobas® 5800/6800/8800 SystemsQQX2025-02-11 View
510(k) K240217 cobas® liat CT/NG nucleic acid testQEP2025-01-17 View
510(k) K240197 cobas® liat CT/NG/MG nucleic acid testQEP2025-01-16 View

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