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510(k) K223016

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

K223016 is an FDA 510(k) premarket notification submitted by Bd for the device "BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit". The FDA issued a decision of Substantially Equivalent on January 27, 2023. The device falls under product code PSZ (Devices Detecting Influenza A, B, And C Virus Antigens), a Class II device regulated under 21 CFR 866.3328. Bd has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 27, 2023
Date Received
September 29, 2022
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.

Other clearances by Bd

  • K253445 — BD Surgiphor™ 1000 mL Antimicrobial Irrigation System (910120) (February 20, 2026)
  • K240257 — Denali™ Vena Cava Filter System – Femoral and Jugular/Subclavian Delivery Kit (February 29, 2024)
  • K232434 — BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit (December 5, 2023)
  • K221504 — BD Surgiphor™ Antimicrobial Irrigation System (October 14, 2022)
  • K180438 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit (March 20, 2018)
  • K024240 — BD VACUTAINER PLUS PLASTIC URINE C&S PRESERVAYIVE TUBES AND KITS (March 26, 2003)
  • K023752 — BD INTEGRA SYRINGE (February 7, 2003)
  • K021475 — BD SINGLE LUMEN NEEDLE, SYRINGE AND BLOOD COLLECTION SET (July 19, 2002)
  • K020523 — BD BIFURCATED NEEDLE, MODELS 301754, 301755, 301756, 301757 (March 20, 2002)
  • K011967 — BD PRE-FILLED HEPARIN LOCK FLUSH IN 0.9% SODIUM CHLORIDE INJECTION, USP SYRINGE (January 23, 2002)

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)
  • K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System (April 18, 2025)
  • K232434 — BD Veritor™ System for Rapid Detection of Flu A+B CLIA Waived Kit (December 5, 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)

FDA data resources