BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    PSP SalivaGene DNA Kit

    DI: 04250306300915 · Model: 50 prep · Invitek Molecular GmbH
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    PSP SalivaGene DNA Kit
    Primary DI
    04250306300915
    Version / Model
    50 prep
    Catalog Number
    1035200200
    Company Name
    Invitek Molecular GmbH
    Labeler DUNS
    331869789
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-09-02
    Public Version
    2
    Public Version Date
    2025-01-21
    Public Version Status
    Update
    Public Device Record Key
    bcf652c8-4829-45fc-9ade-da2ee9a13c1d

    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
    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
    PPM General Purpose Reagent

    GMDN Terms

    Code Name
    52521 Nucleic acid extraction/isolation kit IVD

    Identifiers

    Type ID
    Primary 04250306300915