Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3035708936

FEI Number

3035708936

Entity Name

Bio-Rad Service France SAS

City/State/Country

Mitry Mory Ile-de-France, FR

Establishment Address

Rue des Freres Lumiere, Mitry Mory Ile-de-France 77290, FR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Bio-Rad Laboratories (Bio-Rad Services France) (Owner Number: 10078397)

Owner / Operator Contact Address

Rue Gustave Eiffel, MITRY-MORY, FR-IDF 77290, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K063318

PMA Number

N/A

All Registered Proprietary Names

EVOLIS Microplate System PASTOREX STAPH PLUS PR4100 SA Select IPS Microplate incubator PLATELIA TOXO IgM PLATELIA ASPERGILUS Ag (with peds and BAL claim) Platelia SARS COV 2 Total Ab UriSelect 4 CandiSelect Geenius reader Hemoglobin Capillary Collection System MONOLISA Anti-HAV EIA (manual)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2024-01-17
LHJ	Staphylococcus Aureus Protein A Insoluble	Microbiology	Class 1	866.3700	2025-01-14
JJQ	Colorimeter, Photometer, Spectrophotometer For Clinical Use	Clinical Chemistry	Class 1	862.2300	2025-01-14
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2025-01-14
JRR	Regulator, Temperature	Clinical Chemistry	Class 1	862.2050	2025-01-14
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2025-01-14
NOM	Antigen, Galactomannan, Aspergillus Spp.	Microbiology	Class 1	866.3040	2025-01-14
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2025-01-30
JSH	Culture Media, Non-Selective And Differential	Microbiology	Class 1	866.2320	2025-01-14
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2025-01-14
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2025-01-14
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2025-01-14
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2025-01-14

Official Correspondent

Lucie Watremetz

US Agent Details

David Bhend Business: BIO-RAD LABORATORIES Email: david_bhend@bio-rad.com Phone: (425) 2730193

Related Public Records

Same Entity

Bio-Rad Laboratories (Bio-Rad Services France)

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3016014873	BIO-RAD MEDICAL LABORATORIES LOGISTIK GMBH	Grosskugel /Kabelsketal Saxony-Anhalt, DE

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K760232	Instrumentation Laboratory CO	PRINTER, IL 460	1976-08-26
K862389	Otisville Biotech, Inc.	BIOTIS ACETAMIDE AGAR	1986-07-03
K811644	Hardy Media	HEKTOEN ENTERIC AGAR	1981-07-02
K832535	Otisville Biotech, Inc.	HEKTOEN ENTERIC AGAR PLATE	1983-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.
Z-0008-2024	Ortho-Clinical Diagnostics, Inc.	1	Proboscis/Piston Assembly, Part Number J55375, for VITROS 5,1 FS Chemistry System (Product Code 6801375), VITROS 5,1 Chemistry System (Refurbished) (Product Code 6801890), VITROS 3600 Immunodiagnostic System (Product Code 6802783), VITROS 3600 Immunodiagnostic System (Refurbished) (Product Code 6802914), VITROS 4600 Chemistry System (Product Code 6802445), VITROS 4600 Chemistry System (Refurbished) (Product Code 6900440), VITROS 5600 Integrated System (Product Code 6802413), VITROS 5600 Integrated System (Refurbished) (Product Code 6802915), VITROS XT 3400 Chemistry System (Product Code 6844458), and VITROS XT 7600 Integrated System (Product Code 6844461)
Z-0009-06	Beckman Coulter Inc	1	Synchron LX Systems Version 4.5 Operating Software
Z-0010-06	Abbott Laboratories, Inc	1	ARCHITECT c8000 Analyzer System Processing Module, a fully automated, random access, clinical chemistry analyzer which utilizes spectrophotometry (monochromatic and bichromatic modes of measurement) for photometric based determinations.
Z-0010-2019	Radiometer America Inc	1	ABL90 FLEX analyzers with software versions 3.3MR1 or below. The ABL90 FLEX Analyzer is a portable, automated Analyzer that measures pH, blood gases, electrolytes, glucose, lactate, bilirubin and oximetry in whole blood. It is intended for use in a laboratory environment, near patient or point-of-care setting.

Similar Registrations

Registration Number	Establishment Name	Location
3007500635	Immunodiagnostic Systems SA	Liege, BE
3008853996	Ningbo MedicalSystem Biotechnology Co., Ltd.	Ningbo Zhejiang, CN
1319809	ORTHO-CLINICAL DIAGNOSTICS, INC.	ROCHESTER, NY, US
3000308930	Ortho-Clinical Diagnostics European Support Center	Illkirch, CEDEX Bas-Rhin, FR
3003795116	ROCHE DIAGNOSTICS INTERNATIONAL LTD.	ROTKREUZ Zug, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3035708936. Last updated year: 2026. Please use registration number 3035708936 when referencing this establishment in official correspondence.