BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    FSH ELISA

    DI: 04048474040982 · Model: EIA-4098 · DRG Instruments Gesellschaft mit beschränkter Haftung
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    FSH ELISA
    Primary DI
    04048474040982
    Version / Model
    EIA-4098
    Catalog Number
    EIA-4098
    Company Name
    DRG Instruments Gesellschaft mit beschränkter Haftung
    Labeler DUNS
    317134468
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-08-31
    Public Version
    1
    Public Version Date
    2023-09-08
    Public Version Status
    New
    Public Device Record Key
    b16df290-9e91-4974-88e6-49071472cd03

    Device Description

    For the Quantitative Determination of Follicle Stimulating Hormone Concentration in Human Serum by a Microplate Enzyme Immunoassay, Colorimetric.

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    CGJ Radioimmunoassay, Follicle-Stimulating Hormone

    GMDN Terms

    Code Name
    54186 Follicle stimulating hormone (FSH) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 04048474040982

    Customer Contacts

    Phone
    973-564-7555
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K972720 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius