BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    RIDASCREEN® Echinococcus IgG

    DI: 04049095110511 · Model: K7621 · R-Biopharm AG
    View on AccessGUDID
    Product Codes
    0
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    RIDASCREEN® Echinococcus IgG
    Primary DI
    04049095110511
    Version / Model
    K7621
    Catalog Number
    K7621
    Company Name
    R-Biopharm AG
    Labeler DUNS
    321850323
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-05-08
    Public Version
    3
    Public Version Date
    2023-06-13
    Public Version Status
    Update
    Public Device Record Key
    da32e4d4-b481-4352-869d-a1460cc3c7aa
    Distribution End Date
    2022-12-31

    Device Description

    The RIDASCREEN® Echinococcus IgG test is an enzyme immunoassay for the qualitative determination of IgG antibodies against Echinococcus granulosus und Echinococcus multilocularis in human serum. The test should be used for confirmation purposes when there is a suspected case of infection with Echinococcus.

    Device Characteristics

    Single Use
    No
    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

    GMDN Terms

    Code Name
    52219 Echinococcus granulosus/E. multilocularis immunoglobulin G (IgG) antibody IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 04049095110511