cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit

K190433 is the FDA 510(k) clearance record for cobas TV/MG for use on cobas 6800/8800 systems, cobas TV/MG Positive Control Kit, cobas Buffer Negative Control Kit, a class II device, cleared for Roche Molecular Systems, Inc. on 2019-05-22 under FDA product code QEP (Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections). FDA's definition for product code QEP reads: "A device to detect nucleic acids from non-viral microorganism(s) causing sexually transmitted infections is an in vitro diagnostic device intended for the detection and identification of nucleic acids from non-viral microorganism(s) in...". 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 K190433.