BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Personal Care

    DI: 00808829121612 · Model: Cassette · DELTA BRANDS INC.
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Personal Care
    Primary DI
    00808829121612
    Version / Model
    Cassette
    Company Name
    DELTA BRANDS INC.
    Labeler DUNS
    102672008
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-12-13
    Public Version
    1
    Public Version Date
    2022-12-21
    Public Version Status
    New
    Public Device Record Key
    b0076ec7-a915-42e5-8e78-d0e1383ae87e

    Device Description

    Cannabinoid test is an in vitro diagnostic test for the qualitative analysis of cannabinoids for employment and insurance testing.This Reagent, the Marijuana(THC) Rapid Test Cassette detects 11-nor-Delta9-THC-9-COOH in urine at concentrations equal to or greater than 50 ng/ml. The Marijuana (THC) Test is a rapid qualitative competitive binding immunoassay for determination of Marijuana in urine.

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    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
    55553 Cannabinoid/cannabinoid metabolite IVD, reagent

    Identifiers

    Type ID
    Primary 00808829121612