BEUDAMED
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    Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Enforcement
    Class II ·Terminated·Princeton Biomeditech Corp·September 12, 2012

    BINAXNOW COVID-19 AG SELF TEST OTC

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·June 3, 2022

    ID NOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QJR·November 18, 2020

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 18, 2020

    VITROS IMMUNODIAGNOSTICS PRODUCT ANTI-HIV 1 +2 CONTROLS

    FDA Adverse Event
    Other ·ORTHO-CLINICAL DIAGNOSTICS·Product code MZO·August 5, 2009

    VITROS IMMUNODIAGNOSTIC PRODUCTS SARS-COV-2 ANTIGEN REAGENT

    FDA Adverse Event
    Malfunction ·ORTHO-CLINICAL DIAGNOSTICS·Product code QKP·January 21, 2021

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QKP·February 11, 2021

    Orasure QuickFlu Rapid A+B Test Manufactured for OraSure Technologies, Inc Bethlehem, PA 18015 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Recall
    Terminated ·Princeton Biomeditech Corp·Product code GNX·March 9, 2012

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH INC.·Product code QKP·April 16, 2021

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·November 6, 2020

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 23, 2021

    Status Flu A + B Test Manufactured by Princeton Bio Meditech Corporation Monmouth Junction, NJ 08852 USA. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Recall
    Terminated ·Princeton Biomeditech Corp·Product code GNX·March 9, 2012

    Poly stat Flu A & B Test Manufactured for Polymedco 510 Furnace Dock Road Cortlandt Manor, NY 10567 Tel 800-431-2123 914-739-5400 Fax 914-739-5890. The BioSign Flu A + B test is an in vitro rapid qualitative test that detects influenza type A and type B nucleoprotein antigens directly from nasal swab, nasopharyngeal swab and nasal pharyngeal aspirate/wash specimens obtained from patients with signs and symptoms of respiratory infection. It is intended to aid in the rapid differential diagnosis of influenza A and B viral infections. A negative test result is presumptive and it recommended that these results be confirmed by viral culture. Negative results do not preclude influenza virus infection and should not be used as the sole basis for treatment or other management decisions. The test is intended for professional and laboratory use.

    FDA Recall
    Terminated ·Princeton Biomeditech Corp·Product code GNX·March 9, 2012

    ALERE DETERMINE HIV 1/2 AG/AB COMBO

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCABOROUGH·Product code MZF·May 25, 2021

    LuSys 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Saliva Test)

    FDA Recall
    Open, Classified ·Lusys Laboratories, Inc.·Product code QKP·January 13, 2022

    Luscient Diagnostics 2nd Generation of COVID-19 Viral Antigen Test For all mutant variety Cat: I-114(Nasal Swab Test)

    FDA Recall
    Open, Classified ·Lusys Laboratories, Inc.·Product code QKP·January 13, 2022

    BINAXNOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 15, 2020

    BINAXNOW COVID-19

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH,INC.·Product code QKP·April 13, 2021

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 7, 2021

    BINAX NOW COVID-19 AG CARD

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·January 7, 2021