BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    VIDAS® Progesterone

    DI: 03573026156954 · Model: 30409-01 · BIOMERIEUX SA
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    VIDAS® Progesterone
    Primary DI
    03573026156954
    Version / Model
    30409-01
    Company Name
    BIOMERIEUX SA
    Labeler DUNS
    276816717
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-07-26
    Public Version
    1
    Public Version Date
    2019-08-05
    Public Version Status
    New
    Public Device Record Key
    cb02f718-a496-4d65-8b09-c0187bce5513

    Device Description

    VIDAS ® Progesterone (PRG) assay is a quantitative IA intended for use on VIDAS family instrument in the determination of progesterone 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
    JLS RADIOIMMUNOASSAY, PROGESTERONE

    GMDN Terms

    Code Name
    54324 Progesterone IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 03573026156954

    Premarket Submissions

    Submission Number Supplement Number
    K965084 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius