BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Eu-tTG IgA

    DI: 08028169204024 · Model: 9165 · EUROSPITAL SPA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    Eu-tTG IgA
    Primary DI
    08028169204024
    Version / Model
    9165
    Company Name
    EUROSPITAL SPA
    Labeler DUNS
    429447667
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-07-01
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    dfe9550b-4286-4648-be99-9b9e282eb6c8

    Device Description

    1. Antibody coated plate: 12-1 x 8 wells. 2. Enzyme conjugate antibody (IgA):1x15mL vial. 3. Calibrators: 5 vials containing 1.5 ml human positive serum at five concentrations (0, 10, 20, 50 and 100 AU/ml). 4. Control 1: 1x1.5 mL vial. 5. Control 2: 1x1.5 mL vial. 6. Sample Diluent (10x): 1 x20mL vial. 7. Substrate: 1 x15 ml vial. 8. Wash solution (20x): 1x50 mL vial. 9. Stop Solution: 1 x15 ml vial.

    Device Characteristics

    Single Use
    Yes
    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
    MVM Autoantibodies, Endomysial(Tissue Transglutaminase)

    GMDN Terms

    Code Name
    55223 Tissue transglutaminase antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 08028169204024

    Customer Contacts

    Phone
    +3904089971
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K102964 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius