IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS

FDA Device Registration & Listing · POUILLY EN AUXOIS Cote-d'Or, FR · Registration 9615777

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
9615777
FEI Number
3007034602
Entity Name
IMMUNODIAGNOSTIC SYSTEMS FRANCE SAS
City/State/Country
POUILLY EN AUXOIS Cote-d'Or, FR
Establishment Address
42 Rue Stephane Mazeau, POUILLY EN AUXOIS Cote-d'Or 21320, FR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
IMMUNODIAGNOSTIC SYSTEMS LTD. (Owner Number: 8021924)
Owner / Operator Contact Address
10 DIDCOT WAY, BOLDON BUSINESS PARK, BOLDON COLLIERY, GB-NOTA NE35 9PD, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K161831
PMA Number
N/A

All Registered Proprietary Names

IDS-iSYS 25 VitDS Control Set IDS-iSYS 25 VitDS

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MRG System, Test, Vitamin D Clinical Chemistry Class 2 862.1825 2016-12-08
JJX Single (Specified) Analyte Controls (Assayed And Unassayed) Clinical Chemistry Class 1 862.1660 2016-12-08

Official Correspondent

No official correspondent registered.

US Agent Details

Faith Du Business: Euroimmun US Inc. Email: ra-us@euroimmun.us Phone: (800) 9132022

Related Public Records

Same Entity

IMMUNODIAGNOSTIC SYSTEMS LTD.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3007500635 Immunodiagnostic Systems SA Liege, BE
8021924 IMMUNODIAGNOSTIC SYSTEMS LTD. Boldon Colliery Durham, GB

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K200509 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Vitamin D Total (VitD) 2020-05-29
K103744 Quantimetrix Corp. DROPPER A1C DIABETES CONTROL 2011-05-12
K981281 Roche Diagnostics GmbH ELECSYS CALCHECK FERRITIN 1998-04-24
K981278 Roche Diagnostics GmbH ELECSYS CALCHECK CA 125II 1998-04-23
K143687 Siemens Healthcare Diagnostics, Inc. ADVIA Centaur Follicle Stimulating Hormone (FSH) Master Curve Material, ADVIA Centaur FT4 Master Curve Material, ADVIA Centaur T4 Master Curve Material, ADVIA Centaur T3 Master Curve Material 2015-07-17

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0007-2008 Tosoh Bioscience Inc 1
4 glass vials per box. 2/4ml vials of Sample Diluting Solution & 2/2ml vials of Calibration Verification Material. BetaHCG Calibration Verification Test Set, in vitro diagnostic.

Similar Registrations

Registration Number Establishment Name Location
3007118747 EUROIMMUN US INC. Mountain Lakes, NJ, US
9610126 ROCHE DIAGNOSTICS GMBH MANNHEIM Baden-Wurttemberg, DE
1222302 American Laboratory Products Company Salem, NH, US
8023018 Immunotech SAS, a Beckman Coulter company MARSEILLE, CEDEX 9 Bouches-du-Rhone, FR
2020726 MONOBIND, INC. Lake Forest, CA, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615777. Last updated year: 2026. Please use registration number 9615777 when referencing this establishment in official correspondence.
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