Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003485232

FEI Number

3003485232

Entity Name

AFFINITY BIOLOGICALS INC.

City/State/Country

ANCASTER Ontario, CA

Establishment Address

1348 SANDHILL DRIVE, ANCASTER Ontario L9G 4V5, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AFFINITY BIOLOGICALS INC. (Owner Number: 9072541)

Owner / Operator Contact Address

1348 SANDHILL DRIVE, --, ANCASTER, CA-ON L9G 4V5, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VISULIZE FACTOR VIII ANTIGEN KIT Sheep anti-FXIII-IG-ASR (SAFXIII-IG-ASR-5) Sheep anti-FXIII-IG-ASR (SAFXIII-IG-ASR-500)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GGP	Test, Qualitative And Quantitative Factor Deficiency	Hematology	Class 2	864.7290	2005-07-20
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2007-01-16

Official Correspondent

Janet Lepischak

US Agent Details

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

Related Public Records

Same Entity

AFFINITY BIOLOGICALS INC.

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K972288	Universal Reagents, Inc.	FACTOR DEFICIENT PLASMAS - FACTOR IX (9)	1997-07-14
K010379	Instrumentation Laboratory CO	IL TEST FREE PROTEIN S	2001-04-13
K033631	Instrumentation Laboratory CO	MODIFICATION TO COATEST FACTOR VIII	2003-12-15
K924884	Instrumentation Laboratory CO	IL TEST(TM) PRO-CHROM	1993-01-14
K042576	Instrumentation Laboratory CO	COATEST SP FVIII	2004-12-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0736-2016	Instrumentation Laboratory Co.	2	HemosIL Plasminogen, Part No. 0020009000, IVD. Instrumentation Laboratory Company. Kit contents: 2 x 2.5 mL Streptokinase reagent and 2 x 2 mL Chromogenic substrate
Z-1519-2012	Instrumentation Laboratory Co.	2	Instrumentation Laboratory (IL)HemosIL von Willebrand Factor Activity Assay Kit Part Number: 0020004700 The assay is intended for the quantitative determination of von Willebrand Factor Activity (VWF Activity) in human citrated plasma on IL Coagulation Systems

Similar Registrations

Registration Number	Establishment Name	Location
2431530	INSTRUMENTATION LABORATORY CO.	ORANGEBURG, NY, US
3037000637	INSTRUMENTATION LABORATORY CO. - Devens	Devens, MA, US
9710666	Diagnostica Stago - Taverny	Taverny Val-d'Oise, FR
1217183	INSTRUMENTATION LABORATORY CO.	Bedford, MA, US
2245451	DIAGNOSTICA STAGO, INC.	PARSIPPANY, NJ, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003485232. Last updated year: 2026. Please use registration number 3003485232 when referencing this establishment in official correspondence.