BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    HairCheck-DT (Cocaine)

    DI: 00868586000209 · Model: K023626 · Quest Diagnostics
    View on AccessGUDID
    Product Codes
    3
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HairCheck-DT (Cocaine)
    Primary DI
    00868586000209
    Version / Model
    K023626
    Company Name
    Quest Diagnostics
    Labeler DUNS
    189222334
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-09-23
    Public Version
    2
    Public Version Date
    2018-03-29
    Public Version Status
    Update
    Public Device Record Key
    7cc1b734-46dc-4436-a0c4-d818059ef3c4
    Distribution End Date
    2017-01-13

    Device Description

    HairCheck-DT (Cocaine) is an ELISA test kit used for qualitative detection of Cocaine in head hair with a cutoff of 300 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
    No
    Has Serial Number
    No
    Has Lot/Batch Number
    Yes
    Has Manufacturing Date
    No
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    DIF Drug Mixture Control Materials
    DLJ Calibrators, Drug Specific
    DIO Enzyme Immunoassay, Cocaine And Cocaine Metabolites

    GMDN Terms

    Code Name
    55562 Cocaine/cocaine metabolite IVD, kit, enzyme immunoassay (EIA),

    Identifiers

    Type ID
    Primary 00868586000209