BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    OcculTech Fecal Occult Blood Rapid Test

    DI: 08806125630229 · Model: IM706-100M · YD Diagnostics CORP.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    OcculTech Fecal Occult Blood Rapid Test
    Primary DI
    08806125630229
    Version / Model
    IM706-100M
    Company Name
    YD Diagnostics CORP.
    Labeler DUNS
    687769737
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2019-08-13
    Public Version
    2
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    dcb24a93-9888-4e62-abd5-cf074ac4f42d

    Device Description

    The OcculTech Fecal Occult Blood Rapid Test is a card type rapid test and an immunochomatography based in-vitro test designed for qualitative detection of fecal occult blood that can be performed in laboratories or physicians offices.

    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
    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
    KHE Reagent, Occult Blood

    GMDN Terms

    Code Name
    54531 Faecal occult blood IVD, kit, rapid colorimetric, clinical

    Identifiers

    Type ID
    Primary 08806125630229