Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8010132

FEI Number

3002806808

Entity Name

DIAGNOSTICS BIOCHEM CANADA, INC.

City/State/Country

London Ontario, CA

Establishment Address

384 Neptune Crescent, London Ontario N6M 1A1, CA

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIAGNOSTICS BIOCHEM CANADA, INC. (Owner Number: 8010132)

Owner / Operator Contact Address

384 Neptune Crescent, London, CA-ON N6M 1A1, CA

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Glucagon ELISA (CAN-GLN-390) Androstenedione ELISA (CAN-AD-208) Testosterone (TE) ELISA (CAN-TE-250) 17?-Hydroxyprogesterone (17?-OHP) ELISA (CAN-P-400) 17?-Hydroxyprogesterone (17?-OHP) ELISA (CAN-P-320) 17?-Hydroxyprogesterone (17?-OHP) ELISA (CAN-P-540) Luteinizing Hormone (hLH) ELISA (CAN-LH-4040) Prolactin (PRL) ELISA (CAN-PRL-4100) Estrone ELISA (CAN-E-420, CAN-E-420-8PK) Triiodothyronine (T3) ELISA (CAN-T3-4220) Growth Hormone (hGH) ELISA (CAN-GH-4070) Progesterone ELISA (CAN-P-305) Follicle Stimulating Hormone (hFSH) ELISA (CAN-FSH-4060) Estradiol ELISA (CAN-E-430)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JME	Radioimmunoassay, Glucagon	Clinical Chemistry	Class 1	862.1335	2024-10-08
CIZ	Radioimmunoassay, Androstenedione	Clinical Chemistry	Class 1	862.1075	1977-12-09
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2007-11-20
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2009-05-04
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	1977-12-09
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2003-01-06
CGF	Radioimmunoassay, Estrone	Clinical Chemistry	Class 1	862.1280	2003-01-06
CDP	Radioimmunoassay, Total Triiodothyronine	Clinical Chemistry	Class 2	862.1710	1977-12-09
CFL	Radioimmunoassay, Human Growth Hormone	Clinical Chemistry	Class 1	862.1370	1977-12-09
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	1977-12-09
CGJ	Radioimmunoassay, Follicle-Stimulating Hormone	Clinical Chemistry	Class 1	862.1300	1977-12-09
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	1977-12-09

Official Correspondent

Manon Hogue

US Agent Details

Kevin Walls Business: Regulatory Insight Inc. Email: kevin@reginsight.com Phone: (720) 9625412

Related Public Records

Same Entity

DIAGNOSTICS BIOCHEM CANADA, 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
K971921	Monobind	PROLACTIN (PRL) HORMONE MICROPLATE ELISA	1997-06-24
K931600	Nichols Institute	CHEMILUMINESCENCE FREE T3 IMMUNOASSAY	1993-09-08
K852537	Ria Diagnostics	T-3 RIASSAY	1985-08-12
K780018	Clinical Immuno-Diagnostics	THYRO-INDICATOR T-3 125I	1978-02-07
K833852	Syncor Intl. Corp.	FSH RIA	1984-01-13

Similar Registrations

Registration Number	Establishment Name	Location
3008198807	ANSH LABS, LLC	Webster, TX, US
3009335633	DiaSource ImmunoAssays, SA	Louvain-La-Neuve Brabant Wallon, BE
3003356736	MERCODIA AB	UPPSALA, SE
1222302	American Laboratory Products Company	Salem, NH, US
2133982	IMMUNO-BIOLOGICAL LABORATORIES, INC.	Fridley, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8010132. Last updated year: 2026. Please use registration number 8010132 when referencing this establishment in official correspondence.