BEUDAMED
    Product Code: PSZ FDA class 2 21 CFR 866.3328

    Devices Detecting Influenza A, B, And C Virus Antigens

    Microbiology

    The Devices Detecting Influenza A, B, and C Virus Antigens are qualitative in vitro diagnostic systems intended for the rapid detection of influenza viral antigens directly from clinical specimens in patients with signs and symptoms of respiratory infection, aiding in the diagnosis of influenza A, B, and C. They are classified as FDA Class 2 under 21 CFR 866.3328 in the Microbiology specialty, requiring 510(k) premarket notification. Product code PSZ; not an implant and not life-sustaining.

    View on FDA
    510(k)s
    72
    FEI Numbers
    36
    Registration Numbers
    36
    Unique Applicants
    27
    Years Active
    27

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    Basic Information

    Product Code
    PSZ
    Device Class
    FDA class 2
    Regulation Number
    866.3328
    Medical Specialty
    Microbiology
    Review Panel
    MI
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    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.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 72 510(k) clearances via K numbers.

    K Number Device Name
    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
    K152874 BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit
    K152870 BD Veritor System for the Rapid Detection of Flu A + B CLIA waived 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
    K132259 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B
    K132256 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
    K041441 SAS INFLUENZA A TEST
    K041439 SAS INFLUENZA B TEST
    K031899 QUICKVUE INFLUENZA A+B TEST
    K031565 XPECT INFLUENZA A/B
    K023556 FLU OIA A/B TEST KIT
    K021649 BINAX NOW FLU A TEST (27 TEST), BINAX NOW NASOPHARYNGEAL SWAB SPECIMEN ACCESORY PACK
    K021646 BINAX NOW FLU B 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

    FEI Numbers

    This FDA classification entry is associated with 36 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 36 registration numbers. Click on an entry to view related FDA registrations.