BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    HairCheck-DT (Opiates)

    DI: 00868586000223 · Model: K042725 · Quest Diagnostics
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    HairCheck-DT (Opiates)
    Primary DI
    00868586000223
    Version / Model
    K042725
    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
    4
    Public Version Date
    2022-03-24
    Public Version Status
    Update
    Public Device Record Key
    7cfe9435-b253-419d-ba3b-ddb9c2fd81e1
    Distribution End Date
    2021-07-12

    Device Description

    HairCheck-DT (Opiates) is an ELISA test kit used for qualitative detection of opiates in head hair with a cutoff of 500 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
    DJG Enzyme Immunoassay, Opiates

    GMDN Terms

    Code Name
    55717 Opiate/opiate metabolite IVD, kit, enzyme immunoassay (EIA)

    Identifiers

    Type ID
    Primary 00868586000223