BEUDAMED
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    Pure EP - Dual ECG Splitter Box

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007123·The Dual ECG Splitter Box is an accessory to th...

    Pure EP

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·08567500070008·PURE EP™ is a system consists of two main parts...

    Pure EP - 5 x Single Jumper Cable Black 0.1m

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007116·5 cables in one bag with single jumper cables b...

    Pure EP - Catheter Input Module

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007031·The Catheter Input Module - IC1 J-Box Unipolar/...

    Pure EP - Catheter Input Module

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007048·The Catheter Input Module - IC2 J-Box Bipolar C...

    Pure EP - 5 x 4 pin Yoked Jumper Cable Yellow

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007161·5 cables in one bag with 4 pin yoked jumper cab...

    Pure EP - 5 x 10 pin Yoked Jumper Cable Green

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007154·5 cables in one bag with 10 pin yoked jumper ca...

    Pure EP - 5 x 10 pin Yoked Jumper Cable Blue

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007147·5 cables in one bag with 10 pin yoked jumper ca...

    Pure EP - 5 x 4 pin Yoked Jumper Cable Red

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007178·5 cables in one bag with 4 pin yoked jumper cab...

    Pure EP - 5 x Single Jumper Cable Red 0.3m

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007093·5 cables in one bag with single jumper cables r...

    Pure EP

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007000·PURE EP™ is a system consists of two main parts...

    Pure EP - ECG Cable

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007055·The ECG Cable is an accessory to the PURE EP™ S...

    Pure EP - 5 x 10 pin Yoked Jumper Cable White

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007130·5 cables in one bag with 10 pin yoked jumper ca...

    Pure EP - 5 x Single Jumper Cable Black 0.3m

    FDA UDI
    BIOSIG TECHNOLOGIES, INC.·00856750007109·5 cables in one bag with single jumper cables b...

    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

    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

    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