Product code PSZ— Microbiology
BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
- Classification name
- Devices Detecting Influenza A, B, And C Virus Antigens
- Device class
- Class 2
- Regulation
- 21 CFR 866.3328
- Advisory panel
- Microbiology
- Total cleared
- 72
- First cleared
- Most recent
FDA classification definition
“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.”
Market context for product code PSZ
FDA has cleared devices under product code PSZ between 1998 and 2026, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
last 15 years- 2026
- 2025
- 2023
- 2020
- 2018
- 2017
- 2016
- 2015
- 2014
- 2013
- 2012
- 2011
- 2010
- 2009
- 2008
Top applicants under product code PSZ
Recent clearances under product code PSZ
- K252283 — Nano-Check Influenza A+B Test
- K250398 — Innovita Flu A/B Antigen Rapid Test
- K241188 — Acucy® Influenza A&B Test with the Acucy® 2 System
- K232434 — BD Veritor System for Rapid Detection of Flu A+B CLIA Waived Kit
- K223016 — BD VeritorTM System for Rapid Detection of Flu A+B CLIA-Waived Kit
- K192719 — Osom Ultra Plus Flu A&B Test Kit
- K191514 — CareStart Flu A&B Plus
- K182001 — Acucy Influenza A&B Test with the Acucy System
- K182157 — BioSign Flu A+B
- K181853 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader
- K180438 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
- K180288 — QuickVue Influenza A+B
- K173502 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
- K162438 — Sofia Influenza A+B FIA on Sofia 2
- K162642 — Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
- K160164 — BD Veritor System for Rapid Detection of Flu A + B Labratory Kit
- K160161 — BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
- K153012 — Sofia Influenza A+B FIA
- K152870 — BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit
- K152874 — BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit
- K151291 — BD Veritor (TM) System for the Rapid Detection of Flu A+B
- K151301 — BD Veritor System Flu A+B Assay
- K133714 — TRU FLU
- K133637 — ALERE INFLUENZA A & B TEST
- K133474 — BIOSIGN FLU A + B, STATUS FLU A & B
- K133138 — BD Veritor System Flu A+B Assay
- K132693 — BD Veritor System Flu A+B Assay
- K132692 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
- K132465 — BIOSIGN FLU A + B, STATUS FLU A & B
- K132256 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
- K132259 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
- K121797 — BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
- K120049 — BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
- K112277 — BD VERITOR(TM) SYSTEM FOR RAPID DETECTION OF FLU A+B
- K112177 — SOFIA ANALYZER AND INFLUENZA A+B FIA
- K103610 — CLEARVIEW EXACT II INFLUENZA A & B TEST
- K083746 — BIOSIGN FLU A+B
- K101461 — BD DIRECTIGEN EX FLU A+B
- K101529 — BD DIRECTIGEN EZ FLU A+B ASSAY
- K092349 — CLEARVIEW EXACT II INFLUENZA A & B TEST
- K100227 — SAS FLUALERT A&B, SAS INFLUENZA A TEST
- K093116 — MODIFICATION TO: RAMP INFLUENZA A/B ASSAY
- K092633 — OSOM INFLUENZA A&B TEST , MODEL PN190
- K092698 — QUICKVUE INFLUENZA A+B TEST
- K092553 — TRU FLU, MODEL 751230
- K092423 — XPECT FLU A & B
- K092223 — MODIFICATION TO: BINAXNOW INFLUENZA A & B TEST
- K080380 — SAS INFLUENZA A & B TEST
- K071591 — RAMP INFLUENZA A/B ASSAY
- K071657 — TRU FLU
- K063689 — BD DIRECTIGEN EZ FLU A+B TEST
- K062109 — BINAXNOW INFLUENZA A & B TEST
- K061508 — OSOM INFLUENZA A&B TEST
- K051244 — GENZYME OSOM INFLUENZA A & B TEST
- K053146 — QUICKVUE INFLUENZA A + B TEST
- K053126 — BINAXNOW INFLUENZA A & B TEST
- K042472 — BD DIRECTIGEN EZ FLU A + B
- K041626 — IMMUNOCARD STAT! FLU A & B
- K041049 — BINAXNOW INFLUENZA A & B TEST
- K041439 — SAS INFLUENZA B TEST
- K041441 — SAS INFLUENZA A TEST
- K031899 — QUICKVUE INFLUENZA A+B TEST
- K031565 — XPECT INFLUENZA A/B
- K023556 — FLU OIA A/B TEST KIT
- K021646 — BINAX NOW FLU B TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
- K021649 — BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
- K011684 — INFLUENZA A/B RAPID TEST, CAT NO 2158 663
- K001364 — BD DIRECTIGEN FLU A+B
- K993048 — ROCHE DIAGNOSTICS INFLUENZA A/B RAPID TEST
- K991633 — QUICKVUE INFLUENZA A/B TEST
- K981651 — AB FLU OIA
- K982429 — ZSTATFLU TEST FOR INFLUENZA TYPES A AND B VIRUSES
Data sourced from openFDA. This site is unofficial and independent of the FDA.