BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    INSTANT-VIEW Pregnancy Combo Cassette Test

    DI: 10796918000092 · Model: 02-2489 · ALFA SCIENTIFIC DESIGNS, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    40

    Basic Information

    Brand Name
    INSTANT-VIEW Pregnancy Combo Cassette Test
    Primary DI
    10796918000092
    Version / Model
    02-2489
    Company Name
    ALFA SCIENTIFIC DESIGNS, INC.
    Labeler DUNS
    176391167
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    40
    Record Status
    Published
    Publish Date
    2016-09-21
    Public Version
    4
    Public Version Date
    2023-07-06
    Public Version Status
    Update
    Public Device Record Key
    64636267-42df-479a-8edc-baef51d74e19

    Device Description

    INSTANT-VIEW HCG Combo Cassette Test

    Device Characteristics

    Single Use
    Yes
    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

    Product Codes

    Code Name
    JHI Visual, Pregnancy Hcg, Prescription Use

    GMDN Terms

    Code Name
    33819 Total human chorionic gonadotropin IVD, kit, rapid ICT, clinical

    Identifiers

    Type ID
    Primary 10796918000092
    Unit of Use 00796918000095