Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit

K171792 is the FDA 510(k) clearance record for Alere i Influenza A & B 2, Alere i Instrument, Alere i Influenza A & B Control Swab Kit, a class II device, cleared for Alere Scarborough, Inc. on 2017-09-29 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 17 510(k) clearances for Alere Scarborough, Inc., from 2012-07-26 to 2019-12-02. As of 2026-09-10, FDA records show one recall naming K171792.