Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010305879

FEI Number

3010305879

Entity Name

GENETRACK BIOLABS INC.

City/State/Country

Vancouver British Columbia, CA

Establishment Address

2806 Kingsway Suite 302, Vancouver British Columbia V5R 5T5, CA

Establishment Type(s)

Repack or Relabel Medical Device

Owner / Operator

Genetrack Biolabs Inc. (Owner Number: 10079040)

Owner / Operator Contact Address

2806 Kingsway Suite 200, Vancouver, CA-BC V5R 5T5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered 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

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PQD	Blood Specimen Collection Convenience Kit (Excludes Hiv)	Clinical Chemistry	Class 2	862.1675	2020-11-18
OIE	Urine Collection Kit (Excludes Hiv Testing)	Pathology	Class 1	864.3250	2022-11-29
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2020-11-16
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2020-11-16

Official Correspondent

Clement Ma

US Agent Details

Maureen Garner Business: New World Regulatory Solutions, Inc. Email: NWRSinc@gmail.com Phone: (855) 6977222

Related Public Records

Same Entity

Genetrack Biolabs Inc.

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010305879. Last updated year: 2026. Please use registration number 3010305879 when referencing this establishment in official correspondence.