BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Osteomark NTx Serum

    DI: 10811877010941 · Model: 9021 · Alere Scarborough, Inc.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Osteomark NTx Serum
    Primary DI
    10811877010941
    Version / Model
    9021
    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
    154b3a86-2f8d-4ecc-8105-f9ec3f5142e4

    Device Description

    A test for the quantitative measure of cross-linked N-telopeptides of Type I Collagen (NTx) in human serum as an indicator of bone resorption.

    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 10811877010941