Data / Medical devices / Belgium / DiaSource ImmunoAssays, SA

DiaSource ImmunoAssays, SA: FDA-registered device maker in Louvain-La-Neuve Brabant Wallon, Belgium, 1 510(k) clearance

Name: DiaSource ImmunoAssays, SA FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

DiaSource ImmunoAssays, SA is registered with the FDA (registration 3009335633) in Louvain-La-Neuve Brabant Wallon, Belgium. It lists 19 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 15, 2013. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch DiaSource ImmunoAssays, SA

FDA registration number: 3009335633
Address: Rue du Bosquet 2, Louvain-La-Neuve Brabant Wallon, Belgium, 1348
Owner or operator: DIAsource ImmunoAssays, SA (10037912)
Roles: Manufacturer
First device listed: April 2, 2012
Registered through: 2026
Brand names listed: 11 DOC RIA-CT, 17 OH, 25 OH vit D Total ELISA, ANDROSTENEDIONE -RIA-CT, C PEP ELISA, DHEA-S, E2-RIA-CT, Estrone RIA and more

Devices it lists

Device	Product code	Class	Role	Source
Antigens, All Groups, Streptococcus Spp.	GTY	1	Manufacturer	accessdata.fda.gov
Immunoassay, Insulin-Like Growth Factor Binding Protein-1	OAM	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, 17-Hydroxyprogesterone	JLX	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Androstenedione	CIZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, C-Peptides Of Proinsulin	JKD	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Compound S (11-Deoxycortisol)	JKB	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estradiol	CHP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Estrone	CGF	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Glucagon	JME	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Immunoreactive Insulin	CFP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Luteinizing Hormone	CEP	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Progesterone	JLS	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Prolactin (Lactogen)	CFT	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Thyroxine	CDX	2	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Total Triiodothyronine	CDP	2	Manufacturer	accessdata.fda.gov
Sperm, Antigen, Antiserum, Control	DFQ	1	Manufacturer	accessdata.fda.gov
System, Test, Vitamin D	MRG	2	Manufacturer	accessdata.fda.gov
Test, Follicle Stimulating Hormone (Fsh), Over The Counter	NGA	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 15, 2013	K123364	25OH VITAMIN D TOTAL ELISA TEST	MRG	Substantially Equivalent	Diasource Immunoassays, S.A.	accessdata.fda.gov

Compare with other makers

Updated July 15, 2013. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.