510(k) K232434

BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit by Bd — Product Code PSZ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 5, 2023
Date Received: August 11, 2023
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Devices Detecting Influenza A, B, And C Virus Antigens
Device Class: Class II
Regulation Number: 866.3328
Review Panel: MI
Submission Type

An influenza virus antigen detection test system is a device intended for the qualitative detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection.

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Other clearances for product code PSZ

K252283 — Nano-Check Influenza A+B Test (January 15, 2026)
K250398 — Innovita Flu A/B Antigen Rapid Test (July 3, 2025)
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K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit (January 27, 2023)
K192719 — Osom Ultra Plus Flu A&B Test Kit (April 3, 2020)
K191514 — CareStart Flu A&B Plus (February 18, 2020)
K182001 — Acucy Influenza A&B Test with the Acucy System (December 17, 2018)
K182157 — BioSign Flu A+B (September 18, 2018)
K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader (August 8, 2018)
K180438 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (March 20, 2018)