BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    Abbott iSCREEN URINE TEST DRUG SCREEN CLICK CUP

    Reg #: 3014301129 · FEI: 3014301129 · Expires 2025
    View on FDA
    Products
    11
    Proprietary Names
    4
    Establishment Types
    2
    Classifications
    11

    Registration Details

    Registration Name
    HEALSTONE BIOTECH INC.
    Registration Number
    3014301129
    FEI Number
    3014301129
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    Unit #650 - 655 West Kent Avenue North
    City
    Vancouver British Columbia
    Country
    CA

    Regulatory Submissions

    510(k) Number
    K191841

    Owner / Operator

    Firm Name
    Healstone Biotech Inc.
    Operator Number
    10056764
    Address
    Unit 650, 655 West Kent Ave. N.
    City
    Vancouver
    State
    British Columbia
    Postal Code
    V6P6T7
    Country
    CA
    Correspondent
    Chichi Liu

    Products

    Device Name Product Code
    Test, Amphetamine, Over The Counter NFT
    Test, Phencyclidine (Pcp), Over The Counter NGM
    Test, Opiates, Over The Counter NGL
    Test, Cannabinoid, Over The Counter NFW
    Test, Propoxyphene, Over The Counter QBF
    Test, Methamphetamine, Over The Counter NGG
    Test, Cocaine And Cocaine Metabolites, Over The Counter NFY
    Test, Tricyclic Antidepressants, Over The Counter QAW
    Test, Benzodiazepine, Over The Counter NFV
    Test, Barbiturate, Over The Counter PTH
    Test, Methadone, Over The Counter PTG

    Proprietary Names

    Abbott iSCREEN URINE TEST DRUG SCREEN CLICK CUP Abbott iSCREEN URINE TEST DRUG SCREEN FLAT CUP Healstone Biotech Inc. Accurate Multi Panel Drug Urine Test Cup Rite Aid Corporation Rite Aid Drug Test Kit

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility