Documento fuente o registro público
FDA 510(k) K243406 — cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test
FDA 510(k) index record K243406. Device: cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. Applicant as listed: Roche Molecular Systems, Inc.. Decision date: 2025-04-25.
Fuente
"device_name": "cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test"
Esta entrada describe lo que cubre el documento; el propio documento es la autoridad. Incluirlo no implica estar de acuerdo con sus conclusiones.
Review and references
Automated FDA record verification
2026-10-20
2026-10-25
professional use
FDA 510(k) public index record K243406.
Device name: cobas liat SARS-CoV-2, Influenza A/B & RSV nucleic acid test. Applicant as listed: Roche Molecular Systems, Inc..
Decision date: 2025-04-25. Decision wording: Substantially Equivalent.
Product code: QOF. Regulation: 21 CFR 866.3981. Medical specialty: Microbiology.
This page reproduces regulator index metadata. The applicant field identifies the submitter and is not a manufacturer identity check. Consult the original FDA record for the decision and associated documents; this index does not verify current commercial availability or clinical performance.
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