BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    XL-FDP agglutination reagent

    DI: 00850201006185 · Model: 800DB-LX · Biomedica ADI Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    XL-FDP agglutination reagent
    Primary DI
    00850201006185
    Version / Model
    800DB-LX
    Catalog Number
    800DB-LX
    Company Name
    Biomedica ADI Inc.
    Labeler DUNS
    080600606
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-20
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    b3b98b5f-cdec-457d-ae32-7bdebf4c741e

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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

    Product Codes

    Code Name
    DAP FIBRINOGEN AND FIBRIN SPLIT PRODUCTS, ANTIGEN, ANTISERUM, CONTROL

    GMDN Terms

    Code Name
    47346 D-dimer IVD, kit, agglutination

    Identifiers

    Type ID
    Primary 00850201006185