BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM

    K Number: K992587 · Decision Dec 22, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    15
    Registration Numbers
    15
    Same Product Code
    55
    Applicant Total
    7
    Review Days
    142

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    Basic Information

    Device Name
    EPSTEIN-BARR VIRUS EARLY ANTIGEN (EBV-EA) IGG IFA TEST SYSTEM
    K Number
    K992587
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Stellar Bio Systems, Inc.
    Date Received
    August 2, 1999
    Decision Date
    December 22, 1999
    Product Code
    LSE
    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
    LSE Epstein-Barr Virus, Other

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    Other Clearances by Stellar Bio Systems, Inc.

    K Number Device Name
    K990916 INDIRECT FLUORESCENCE ASSAY FOR ANTI-NATIVE DNA IGG ANTIBODY
    K990915 INDIRECT FLUORESCENCE ASSAY FOR ANTI-NUCLEAR ANTIBODIES IGG ANTIBODY
    K914953 IFA FOR CHLAMYDIA TRACHOMATIS IGG ANTIBODY
    K905608 INDIRECT FLUORESCENT ASSAY FOR HERPES SIMPLEX 1
    K900974 INDIRECT FLUORESCENT ASSAY FOR (EBV-VCA) IGG ANTI.
    K882835 INDIRECT FLUORESCENT ASSAY FOR (HCMV)