BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HCG SERUM CONTROLS

    DI: 00695684710033 · Model: 71003 · GERMAINE LABORATORIES, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    2
    Pkg Device Count
    3

    Basic Information

    Brand Name
    HCG SERUM CONTROLS
    Primary DI
    00695684710033
    Version / Model
    71003
    Company Name
    GERMAINE LABORATORIES, INC
    Labeler DUNS
    176458115
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    3
    Record Status
    Published
    Publish Date
    2016-04-27
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    64bd6fd2-ed76-47d5-9e42-26181847868a

    Device Description

    Tri-level, For use with qualitative hCG serum tests.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    Yes
    Over the Counter (OTC)
    No
    Kit
    No
    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
    JJY Multi-Analyte Controls, All Kinds (Assayed)

    GMDN Terms

    Code Name
    30219 Multiple urine analyte IVD, control

    Identifiers

    Type ID
    Primary 00695684710033
    Unit of Use 00695684710034