BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    EL-ANCA: anti-MPO

    DI: 00854473003248 · Model: 104-114 · THERA-TEST LABORATORIES, INC
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    EL-ANCA: anti-MPO
    Primary DI
    00854473003248
    Version / Model
    104-114
    Catalog Number
    104-114
    Company Name
    THERA-TEST LABORATORIES, INC
    Labeler DUNS
    194336954
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-15
    Public Version
    3
    Public Version Date
    2023-07-07
    Public Version Status
    Update
    Public Device Record Key
    aedd49ec-20be-4786-8788-2528b1ff79c7

    Device Description

    ANTI-MYELOPEROXIDASE (MPO) ANTIBODIES (P-ANCA) ELISA TEST KIT, 96 TESTS

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    Yes
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    GMDN Terms

    Code Name
    55068 Myeloperoxidase anti-neutrophil cytoplasmic antibody (MPO-ANCA) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00854473003248

    Premarket Submissions

    Submission Number Supplement Number
    K061376 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius