BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FEBRILE POSITIVE CONTROL

    DI: 00695684016005 · Model: 1600 · GERMAINE LABORATORIES, INC
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    FEBRILE POSITIVE CONTROL
    Primary DI
    00695684016005
    Version / Model
    1600
    Company Name
    GERMAINE LABORATORIES, INC
    Labeler DUNS
    176458115
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-04-21
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    9a721103-333c-417f-a379-c3c17267201e

    Device Description

    Febrile Positive Control is intended for use as a positive control for Febrile Antigen 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
    Yes
    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
    GSN Antiserum, Positive And Negative Febrile Antigen Control Serum

    GMDN Terms

    Code Name
    32502 Multiple febrile infection-associated bacteria antigen IVD, control

    Identifiers

    Type ID
    Primary 00695684016005