BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ZDMC

    DI: 06976045540242 · Model: 1 test/kit · Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ZDMC
    Primary DI
    06976045540242
    Version / Model
    1 test/kit
    Company Name
    Zhide Mingchuang Biotechnology (Wuxi) Co., Ltd.
    Labeler DUNS
    601499444
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-03-17
    Public Version
    2
    Public Version Date
    2023-05-08
    Public Version Status
    Update
    Public Device Record Key
    a0eee50c-1328-4609-a832-bc70e94c335e

    Device Description

    This kit is intended for qualitative detection of the matrix metalloproteinase-9 (MMP-9) in human ocular surface rinsing fluid for the auxiliary diagnosis of dry eye disease.

    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
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PFQ Mmp-9 Test System

    GMDN Terms

    Code Name
    60562 Matrix metalloproteinase-9 (MMP-9) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 06976045540242