BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ASCA-CHEK

    DI: 00857031002325 · Model: T5016 · TECHLAB, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ASCA-CHEK
    Primary DI
    00857031002325
    Version / Model
    T5016
    Company Name
    TECHLAB, INC.
    Labeler DUNS
    614218634
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-20
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    58823104-4221-4226-b978-04b1c67d0417

    Device Description

    The ASCA-CHEK test is an enzyme-linked immunosorbent assay (ELISA) for the qualitative detection of human anti-S. cerevisiae antibodies (ASCA) in feces and serum. The test result is used as an aid in the diagnosis of Crohn’s disease in combination with clinical and other laboratory findings. FOR IN VITRO DIAGNOSTIC USE.

    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
    NBT Antibodies,Saccharomyces Cerevisiae (S.Cerevisiae)

    GMDN Terms

    Code Name
    52112 Saccharomyces cerevisiae total antibody IVD, kit enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00857031002325