Influenza a Subtyping Kit, Cdc Human Influenza Virus Real-Time Rt-PCR Diagnostic Panel

K140851 is the FDA 510(k) clearance record for INFLUENZA A SUBTYPING KIT, CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL, a class II device, cleared for Centers for Disease Control and Prevention on 2014-04-25 under FDA product code OEP (Influenza A Virus Subtype Differentiation Nucleic Acid Assay). FDA's definition for product code OEP reads: "A qualitative in vitro diagnostic assay intended to detect and differentiate between influenza a virus subtypes in human respiratory specimens or viral culture. Detection and differentiation of specific subtype rna aids in the diagnosis of...". 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 K140851.