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    FDA UDI In Commercial Distribution 🇺🇸 United States

    Gentian Cystatin C Single Use Control High

    DI: 07090038460122 · Model: 1030 · Gentian AS
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Gentian Cystatin C Single Use Control High
    Primary DI
    07090038460122
    Version / Model
    1030
    Company Name
    Gentian AS
    Labeler DUNS
    730958121
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-11-18
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    95de8187-80f7-438e-86b5-fa929d52621a

    Device Description

    The Gentian Cystatin C Controls are intended to be used to evaluate the quality of the calibration curve established from Gentian Cystatin C Calibrator with the Gentian Cystatin C Immunoassay.

    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
    NDY Test, Cystatin C

    GMDN Terms

    Code Name
    48175 Cystatin C IVD, control

    Identifiers

    Type ID
    Primary 07090038460122

    Premarket Submissions

    Submission Number Supplement Number
    K071388 000