Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009335633

FEI Number

3009335633

Entity Name

DiaSource ImmunoAssays, SA

City/State/Country

Louvain-La-Neuve Brabant Wallon, BE

Establishment Address

Rue du Bosquet 2, Louvain-La-Neuve Brabant Wallon 1348, BE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

DIAsource ImmunoAssays, SA (Owner Number: 10037912)

Owner / Operator Contact Address

Rue du Bosquet, 2, Louvain-La-Neuve, BE-NOTA 1348, BE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

IGFBP-3 ELISA E2-RIA-CT ANDROSTENEDIONE -RIA-CT Glucagon DHEA-S PRL 17 OH Insulin 11 DOC RIA-CT Estrone RIA T4-RIA-CT LHsp

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
OAM	Immunoassay, Insulin-Like Growth Factor Binding Protein-1	Clinical Chemistry	Class 1	862.1550	2012-04-02
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2012-04-02
CIZ	Radioimmunoassay, Androstenedione	Clinical Chemistry	Class 1	862.1075	2012-04-02
JME	Radioimmunoassay, Glucagon	Clinical Chemistry	Class 1	862.1335	2018-09-03
JKC	Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	Clinical Chemistry	Class 1	862.1245	2012-04-02
CFT	Radioimmunoassay, Prolactin (Lactogen)	Clinical Chemistry	Class 1	862.1625	2017-08-04
JLX	Radioimmunoassay, 17-Hydroxyprogesterone	Clinical Chemistry	Class 1	862.1395	2012-04-02
CFP	Radioimmunoassay, Immunoreactive Insulin	Clinical Chemistry	Class 1	862.1405	2012-04-02
JKB	Radioimmunoassay, Compound S (11-Deoxycortisol)	Clinical Chemistry	Class 1	862.1185	2018-03-27
CGF	Radioimmunoassay, Estrone	Clinical Chemistry	Class 1	862.1280	2014-08-04
CDX	Radioimmunoassay, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2022-08-22
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2017-08-04

Official Correspondent

No official correspondent registered.

US Agent Details

Mark Kowal Business: Immuno-Biological Laboratories, Inc. (IBL-America) Email: mkowal@ibl-america.com Phone: (763) 7802955

Related Public Records

Same Entity

DIAsource ImmunoAssays, SA

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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009335633. Last updated year: 2026. Please use registration number 3009335633 when referencing this establishment in official correspondence.