BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Fingerstick Sample Collection Kit

    DI: 00811877010395 · Model: 2604US199 · Alere Scarborough, Inc.
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Fingerstick Sample Collection Kit
    Primary DI
    00811877010395
    Version / Model
    2604US199
    Company Name
    Alere Scarborough, Inc.
    Labeler DUNS
    154148498
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-01-13
    Public Version
    2
    Public Version Date
    2023-09-14
    Public Version Status
    Update
    Public Device Record Key
    f293c336-e865-4dc7-8dd9-1c380d62aeb5
    Distribution End Date
    2024-07-01

    Device Description

    Kit Intended to facilitate fingerstick whole blood sampling.

    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

    GMDN Terms

    Code Name
    48450 HIV1/HIV2 antigen/antibody IVD, reagent

    Identifiers

    Type ID
    Primary 00811877010395