BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    digene® HC2 GC-ID DNA Test

    DI: 04053228010296 · Model: 2 · QIAGEN SCIENCES INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    digene® HC2 GC-ID DNA Test
    Primary DI
    04053228010296
    Version / Model
    2
    Catalog Number
    5140-1220
    Company Name
    QIAGEN SCIENCES INC.
    Labeler DUNS
    008675485
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2017-01-04
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    99470833-91a7-43f8-ba4b-d35d969afdf3

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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
    LSL Dna-Reagents, Neisseria

    GMDN Terms

    Code Name
    51235 Neisseria gonorrhoeae nucleic acid IVD, kit, nucleic acid technique (NAT)

    Identifiers

    Type ID
    Primary 04053228010296