BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VIDAS® FSH

    DI: 03573026156947 · Model: 30407-01 · BIOMERIEUX SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VIDAS® FSH
    Primary DI
    03573026156947
    Version / Model
    30407-01
    Company Name
    BIOMERIEUX SA
    Labeler DUNS
    276816717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-09-25
    Public Version
    1
    Public Version Date
    2019-10-03
    Public Version Status
    New
    Public Device Record Key
    24fcfc12-95ed-481f-a1d8-fa4a7d4cd627

    Device Description

    VIDAS® FSH (FSH) assay is a quantitative immunoassay intended for use on VIDAS family instrument in the detection of FSH concentration in human serum or plasma

    Device Characteristics

    Single Use
    No
    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
    No
    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 03573026156947

    Premarket Submissions

    Submission Number Supplement Number
    K921746 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius