BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    VIRGO HSV-2 IGG ELISA

    K Number: K883281 · Decision Mar 10, 1989
    View on FDA
    Classifications
    1
    FEI Numbers
    6
    Registration Numbers
    6
    Same Product Code
    15
    Applicant Total
    9
    Review Days
    219

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    Basic Information

    Device Name
    VIRGO HSV-2 IGG ELISA
    K Number
    K883281
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    866.3305
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Applicant
    Electro-Nucleonics, Inc.
    Date Received
    August 3, 1988
    Decision Date
    March 10, 1989
    Product Code
    GQO
    Advisory Committee
    Microbiology
    Review Advisory Committee
    MI
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    GQO Antisera, Cf, Herpesvirus Hominis 1,2

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    Other Clearances by Electro-Nucleonics, Inc.

    K Number Device Name
    K893718 DELTATEST (R) LIPASE II
    K883670 SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VI
    K883427 VIRGO(R) VZV-IGG ELISA
    K883282 VIRGO HSV-1 IGG ELISA
    K883102 VIRGO (R) CMV-IGG ELISA
    K884784 VIRGO(R) MICROWELL ALT ASSAY
    K883205 ALTLTS ALANINE AMINO TRANSFERASE ALT
    K883206 LACTATE DEHYDROGENASE LDH