BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Osteomark NTx Urine

    DI: 10811877010934 · Model: 9006 · Alere Scarborough, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Osteomark NTx Urine
    Primary DI
    10811877010934
    Version / Model
    9006
    Company Name
    Alere Scarborough, Inc.
    Labeler DUNS
    154148498
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2020-09-16
    Public Version
    2
    Public Version Date
    2023-09-14
    Public Version Status
    Update
    Public Device Record Key
    0e059518-e307-492c-b39f-42ba403a7fbb

    Device Description

    An enzyme-linked immunosorbent assay (EIA) for the measurement of cross-linked N-telopeptides of Type I Collagen (NTx) in human urine.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    JMM Column Chromatography & Color Development, Hydroxyproline

    GMDN Terms

    Code Name
    53636 Collagen type I cross-linked N-telopeptide IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 10811877010934