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    FDA UDI In Commercial Distribution 🇺🇸 United States

    VDRL CONTROL SERUM KIT

    DI: B224V611 · Model: V-61 · CENOGENICS CORPORATION
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

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    Basic Information

    Brand Name
    VDRL CONTROL SERUM KIT
    Primary DI
    B224V611
    Version / Model
    V-61
    Company Name
    CENOGENICS CORPORATION
    Labeler DUNS
    068288943
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2021-05-27
    Public Version
    1
    Public Version Date
    2021-06-04
    Public Version Status
    New
    Public Device Record Key
    de7e8862-346b-47d8-b403-50bbb29b3860

    Device Description

    Cenogenics Corporation's VDRL CONTROL SERUM KIT is a set of syphilitic and non-syphilitic human sera for use with the VDRL slide flocculation test for detection of antibodies to Treponema pallidum. The kit contains: 5ml VDRL Reactive Control Serum 5ml VDRL Weakly Reactive Control Serum 5ml VDRL Nonreactive Control Serum Product Instructions

    Device Characteristics

    Single Use
    Yes
    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
    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
    GMP Antisera, Control For Nontreponemal Tests

    GMDN Terms

    Code Name
    51792 Treponema pallidum antigen IVD, control

    Identifiers

    Type ID
    Primary B224V611