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

K243400 is the FDA 510(k) clearance record for cobas liat SARS-CoV-2 & Influenza A/B v2 nucleic acid test, a class II device, cleared for Roche Molecular Systems, Inc. on 2025-04-25 under FDA product code QOF (Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents). FDA's definition for product code QOF reads: "A device to detect and identify nucleic acid targets in respiratory specimens from microbial agents that cause the SARS-CoV-2 respiratory infection and other microbial agents when in a multi-target test is an in vitro diagnostic device...". FDA records list 53 510(k) clearances for Roche Molecular Systems, Inc., from 1993-06-15 to 2026-07-16. As of 2026-09-10, FDA records show no recalls naming K243400.