Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003935253

FEI Number

3003935253

Entity Name

THERADIAG

City/State/Country

MARNE LA VALLEE CEDEX 2 Seine-et-Marne, FR

Establishment Address

14 rue AMBROISE CROIZAT, CS 90136 CROISSY BEAUBOURG, MARNE LA VALLEE CEDEX 2 Seine-et-Marne 77435, FR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

THERADIAG (Owner Number: 9065218)

Owner / Operator Contact Address

14 rue AMBROISE CROIZAT, CS 90136 CROISSY BEAUBOURG, MARNE LA VALLEE CEDEX 2, FR-NOTA 77435, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K053653

PMA Number

N/A

All Registered Proprietary Names

IMMUNO-TROL FIDIS CONNECTIVE 10

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DGR	Whole Human Serum, Antigen, Antiserum, Control	Immunology	Class 1	866.5700	2015-07-08
LKO	Anti-Rnp Antibody, Antigen And Control	Immunology	Class 2	866.5100	2005-01-07
LSW	Anti-Dna Antibody, Antigen And Control	Immunology	Class 2	866.5100	2005-01-07
LKJ	Antinuclear Antibody, Antigen, Control	Immunology	Class 2	866.5100	2005-01-07
LLL	Extractable Antinuclear Antibody, Antigen And Control	Immunology	Class 2	866.5100	2005-01-07
LJM	Antinuclear Antibody (Enzyme-Labeled), Antigen, Controls	Immunology	Class 2	866.5100	2005-01-07
LKP	Anti-Sm Antibody, Antigen And Control	Immunology	Class 2	866.5100	2005-01-07
MQA	Anti-Ribosomal P Antibodies	Immunology	Class 2	866.5100	2005-01-07

Official Correspondent

Evelyne KOERTJE

US Agent Details

Thomas Ippolito Business: Chembio Diagnostic Systems Email: tippolito@chembio.com Phone: (631) 9241135

Related Public Records

Same Entity

THERADIAG

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
K000755	Rhigene, Inc.	RHIGENE MESACUP2 TEST- SM	2000-05-09

Similar Registrations

Registration Number	Establishment Name	Location
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
1319681	ORTHO-CLINICAL DIAGNOSTICS, INC.	Rochester, NY, US
3009189893	Agilent Technologies Inc.	Cedar Creek, TX, US
3017237798	HEMO BIOSCIENCE	Durham, NC, US
3015376545	IMMCO DIAGNOSTICS, INC.	Williamsville, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003935253. Last updated year: 2026. Please use registration number 3003935253 when referencing this establishment in official correspondence.