BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ZEUS NTx Urine

    DI: 00845533001878 · Model: NTx9006 · ZEUS SCIENTIFIC, INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ZEUS NTx Urine
    Primary DI
    00845533001878
    Version / Model
    NTx9006
    Company Name
    ZEUS SCIENTIFIC, INC.
    Labeler DUNS
    080953946
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-04-18
    Public Version
    1
    Public Version Date
    2023-04-26
    Public Version Status
    New
    Public Device Record Key
    aa4282eb-17e0-4ab0-a3cf-0db495ceb890

    Device Description

    An enzyme-linked immunosorbent assay (ELISA) for the quantitative measurement of cross-linked, N-telopeptides of Type 1 collagen (NTx) in human urine.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    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
    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 00845533001878