BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇪🇸 Spain

    ADVIA Centaur EBV-EBNA IgG

    K Number: K233605 · Decision Aug 7, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    26
    Applicant Total
    23
    Review Days
    272

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    Basic Information

    Device Name
    ADVIA Centaur EBV-EBNA IgG
    K Number
    K233605
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    866.3235
    Medical Specialty
    Microbiology
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Biokit, S.A.
    Date Received
    November 9, 2023
    Decision Date
    August 7, 2024
    Product Code
    LLM
    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
    LLM Test, Antigen, Nuclear, Epstein-Barr Virus

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    Other Clearances by Biokit, S.A.

    K Number Device Name
    K243575 ARCHITECT HSV-2 IgG, ARCHITECT HSV-2 IgG Calibrator, ARCHITECT HSV-2 IgG Controls
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    K213987 ARCHITECT HSV-1 IgG, ARCHITECT HSV-1 IgG Calibrator, ARCHITECT HSV-1 IgG Controls
    K214068 Quantia IgE
    K181334 ADVIA Centaur Herpes-2 IgG
    K181333 ADVIA Centaur Herpes-1 IgG
    K152185 ARCHITECT SHBG
    K132400 LP(A) CALIBRATORS, AND LP(A) CONTROLS
    K123947 ARCHITECT IVANCOMYCIN
    K110619 ARCHITECT 25-OH VITAMIN D 100T, VITAMIN D 500T, VITAMIN D CALIBRATORS, VITAMIN D CONTROLS
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