BEUDAMED
    FDA UDI Not in Commercial Distribution 🇺🇸 United States

    First Check

    DI: 00643281061553 · Model: One Drug Marijuana · FIRST CHECK DIAGNOSTIC CORP.
    View on AccessGUDID
    Product Codes
    2
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    First Check
    Primary DI
    00643281061553
    Version / Model
    One Drug Marijuana
    Catalog Number
    THC
    Company Name
    FIRST CHECK DIAGNOSTIC CORP.
    Labeler DUNS
    945331317
    Distribution Status
    Not in Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2016-06-22
    Public Version
    6
    Public Version Date
    2022-11-28
    Public Version Status
    Update
    Public Device Record Key
    b0018d0f-3ea6-4f22-b23a-222f1a598d43
    Distribution End Date
    2021-03-31

    Device Description

    First Check Home Drug Test One Drug Marijuana

    Device Characteristics

    Single Use
    Yes
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    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
    Yes
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    LDJ Enzyme Immunoassay, Cannabinoids
    NFW Test, Cannabinoid, Over The Counter

    GMDN Terms

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

    Identifiers

    Type ID
    Primary 00643281061553

    Customer Contacts

    Phone
    1-888-788-5716
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K052115 000

    Storage Conditions

    Type
    Storage Environment Temperature
    Temperature Range
    40 – 86 Degrees Fahrenheit