Cdc Human Influenza Virus Real-Time Rt- PCR Detection and Characterization Panel

K080570 is the FDA 510(k) clearance record for CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL, a class II device, cleared for Centers for Disease Control and Prevention on 2008-09-30 under FDA product code NXD (Nucleic Acid Amplification, Novel Influenza A Virus, A/H5 (Asian Lineage) Rna). FDA's definition for product code NXD reads: "Novel influenza a virus reagents are used in nucleic acid amplification tests to directly detect and differentiate novel influenza a virus specific rna gene segments in human respiratory specimens or viral cultures. Detection and...". FDA records list 30 510(k) clearances for Centers for Disease Control and Prevention, from 1981-09-08 to 2026-03-30. As of 2026-09-10, FDA records show no recalls naming K080570.