Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System

K191729 is the FDA 510(k) clearance record for Cobas Influenza A/B Nucleic Acid Test for Use on the Cobas Liat System, a class II device, cleared for Roche Molecular Systems, Inc. on 2019-07-24 under FDA product code OCC (Respiratory Virus Panel Nucleic Acid Assay System). FDA's definition for product code OCC reads: "A respiratory viral panel multiplex nucleic acid assay is a qualitative in vitro diagnostic device intended to simultaneously detect and identify multiple viral nucleic acids extracted from human respiratory specimens or viral culture. The...". 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 K191729.