cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K243406 FDA 510(k)
- FDA Product Code
- QOF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 866.3981 FDA 510(k)
- Regulation Number
- 866.3981 FDA 510(k)
- Advisory Committee
- Microbiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test is a Multi-Target Respiratory Specimen Nucleic Acid Test designed for the simultaneous detection of SARS-CoV-2, Influenza A and B viruses, and Respiratory Syncytial Virus (RSV) from respiratory specimens. It employs automated rapid multiplex real-time reverse transcription polymerase chain reaction (RT-PCR) technology to identify multiple pathogens in a single assay, enabling accurate and efficient diagnostic results.
This device is intended for use in Point of Care (POC) settings operating under a CLIA Certificate of Waiver, Compliance, or Accreditation. Supplied as a single-use in vitro diagnostic reagent system, it requires no additional sterilisation and is regulated under FDA 510(k) clearance and IVDD compliance. The test is classified as Class II and adheres to regulatory requirements outlined under 21 CFR 866.3981.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: cobas® liat SARS-CoV-2, Influenza A/B & RSV, nucleic acid test, cobas® liat SARS-CoV-2, Influenza A/B & RSV assay - Roche Diagnostics USA, PDF cobas® liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
Authorization Coverage (2 countries)
Regulatory Authorizations
IVDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | IVDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K243406 | Class II | Active |
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Manufacturer
- Manufacturer
- Roche Molecular Systems, Inc.
Sources (2)
- FDA 510(k) K243406 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026