BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    HairCheck-DT (THC) Exempt

    DI: 00868586000261 · Model: PVJ-Exempt · Quest Diagnostics
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HairCheck-DT (THC) Exempt
    Primary DI
    00868586000261
    Version / Model
    PVJ-Exempt
    Company Name
    Quest Diagnostics
    Labeler DUNS
    189222334
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2023-07-11
    Public Version
    1
    Public Version Date
    2023-07-19
    Public Version Status
    New
    Public Device Record Key
    d3639230-cc84-494e-9eb3-b936e9b97055

    Device Description

    HairCheck-DT (THC) is an ELISA test kit used for qualitative detection of THC-COOH in head hair with a cutoff of 1.0 pg/mg of hair. Kit is comprised of 4 component packages: Microplates, Conjugate Reagents, Common Reagents, and Calibrator/Controls.

    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
    Yes
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    Yes
    Has Expiration Date
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    PVJ Test, Cannabinoid, Employment And Insurance Testing, Exempt

    GMDN Terms

    Code Name
    55550 Cannabinoid/cannabinoid metabolite IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00868586000261