BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elecsys FSH

    DI: 04015630909223 · Model: 11775863122 · Roche Diagnostics GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Elecsys FSH
    Primary DI
    04015630909223
    Version / Model
    11775863122
    Catalog Number
    11775863122
    Company Name
    Roche Diagnostics GmbH
    Labeler DUNS
    315028860
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-03-13
    Public Version
    1
    Public Version Date
    2020-03-23
    Public Version Status
    New
    Public Device Record Key
    a9c0bc5d-705c-45b2-945b-c5b6dc537fdf

    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
    CGJ RADIOIMMUNOASSAY, FOLLICLE-STIMULATING HORMONE

    GMDN Terms

    Code Name
    54187 Follicle stimulating hormone (FSH) IVD, kit, chemiluminescent immunoassay

    Identifiers

    Type ID
    Primary 04015630909223

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius