cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit

DEN200015 is the FDA 510(k) clearance record for cobas EBV, cobas EBV/BKV Control Kit, cobas Buffer Negative Control Kit, a class II device, cleared for Roche Molecular Systems, Inc. on 2020-07-30 under FDA product code QLX (Nucleic Acid Amplification Test For The Quantitation Of Epstein-Barr Virus (Ebv) Dna). FDA's definition for product code QLX reads: "A quantitative viral nucleic acid test for transplant patient management is identified as a device intended for prescription use in the detection of viral pathogens by measurement of viral deoxyribonucleic acid (DNA) or ribonucleic acid...". 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 DEN200015.