BEUDAMED
    FDA Registration Active 🇨🇦 Canada

    GENETRACK BIOLABS INC.

    Reg #: 3010305879 · FEI: 3010305879 · Expires 2026
    View on FDA
    Products
    5
    Proprietary Names
    6
    Establishment Types
    2
    Classifications
    5

    Registration Details

    Registration Name
    GENETRACK BIOLABS INC.
    Registration Number
    3010305879
    FEI Number
    3010305879
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    2806 Kingsway Suite 302
    City
    Vancouver British Columbia
    Country
    CA

    Regulatory Submissions

    PMA Number
    BP090080

    Owner / Operator

    Firm Name
    Genetrack Biolabs Inc.
    Operator Number
    10079040
    Address
    2806 Kingsway Suite 200
    City
    Vancouver
    State
    British Columbia
    Postal Code
    V5R 5T5
    Country
    CA
    Correspondent
    Clement Ma

    US Agent

    Business Name
    New World Regulatory Solutions, Inc.
    Contact Name
    Maureen Garner
    Address
    11700 W Charleston Blvd, Suite 170 - 390
    City
    Las Vegas
    State
    NV
    ZIP
    89135
    Country
    US
    Email
    [email protected]
    Phone
    855 6977222

    Products

    Device Name Product Code
    Blood Specimen Collection Convenience Kit (Excludes Hiv) PQD
    Urine Collection Kit (Excludes Hiv Testing) OIE
    Container, Specimen Mailer And Storage, Non-Sterile NNK
    Applicator, Absorbent Tipped, Non-Sterile KXF
    Test, Hiv Detection MZF

    Proprietary Names

    Blood Sample Collection Kit Genetrack Blood Sample Collection Kit Genetrack Urine Sample Collection Kit Urine Sample Collection Kit Genetrack Swab Sample Collection Kit Swab Sample Collection Kit

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)