BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    ZYMUTEST HIA MonoStrip IgG

    DI: 03663537046803 · Model: RK041A · HYPHEN BIOMED
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    ZYMUTEST HIA MonoStrip IgG
    Primary DI
    03663537046803
    Version / Model
    RK041A
    Catalog Number
    RK041A
    Company Name
    HYPHEN BIOMED
    Labeler DUNS
    503499167
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-08-25
    Public Version
    3
    Public Version Date
    2018-07-06
    Public Version Status
    Update
    Public Device Record Key
    dac2ea18-c5b8-4921-ace4-d1b3c6c546dd

    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
    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
    LCO Platelet Factor 4 Radioimmunoassay

    GMDN Terms

    Code Name
    53783 Total immunoglobulin G (IgG total) IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 03663537046803

    Premarket Submissions

    Submission Number Supplement Number
    K071255 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    2 – 8 Degrees Celsius