Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003871407

FEI Number

3003871407

Entity Name

BIOLYTICAL LABORATORIES INC.

City/State/Country

Richmond British Columbia, CA

Establishment Address

406 - 13251 Delf Place, Richmond British Columbia V6V2A2, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biolytical Laboratories Inc. (Owner Number: 10038129)

Owner / Operator Contact Address

406 - 13251 Delf Place, Richmond, CA-BC V6V 2A2, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

BP251179

All Registered Proprietary Names

INSTI HIV-1, Control Test Kit INSTI HIV-1/HIV-2 Control Test Kit INSTI HIV-1/2 Antibody Test Kit (INSTI) INSTI HIV Self Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MZF	Test, Hiv Detection	Microbiology	Class 2	866.3956	2011-09-16
QSS	Hiv Self-Tests	Unknown	Class 3	N/A	2025-11-14

Official Correspondent

No official correspondent registered.

US Agent Details

Yong Sun Business: Emergo Global Representation LLC Email: USAgent@UL.com Phone: (512) 3279997

Related Public Records

Same Entity

Biolytical Laboratories 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 3003871407. Last updated year: 2026. Please use registration number 3003871407 when referencing this establishment in official correspondence.