Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8023060

FEI Number

3003992026

Entity Name

BIO-RAD

City/State/Country

STEENVOORDE Nord, FR

Establishment Address

ROUTE DE CASSEL, STEENVOORDE Nord 59114, FR

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

BIO-RAD (Owner Number: 8023061)

Owner / Operator Contact Address

3 BOULEVARD RAYMOND POINCARE, --, MARNES-LA-COQUETTE, FR-NOTA 92430, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VRE Select (stool claim) ACCESS RUBELLA IGG ACCESS CEA MONOLISA anti-HAV EIA on EVOLIS Uriselect 4 CandiSelect SA Select PLATELIA Toxo IgM kit Anti-HIV Antibody ASR MONOLISA anti-HAV IgM EIA on EVOLIS Platelia Aspergillus Ag Hemoglobin Capillary Collection System ACCESS TOXO IgG PASTOREX STAPH-PLUS Platelia SARS COV 2 Total Ab Geenius HIV 1/2 Supplemental Assay MONOLISA ANTI-HAV IGM EIA ACCESS SYPHILIS ACCESS CEA ACCESS TOXO IgG ACCESS TOXO IGM II MONOLISA ANTI-HAV EIA ACCESS TOXO IgM II

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSO	Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar	Microbiology	Class 2	866.1700	2012-12-05
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	1996-07-16
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2006-06-29
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2009-12-01
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2009-12-01
JSH	Culture Media, Non-Selective And Differential	Microbiology	Class 1	866.2320	2011-01-25
JSI	Culture Media, Selective And Differential	Microbiology	Class 1	866.2360	2010-12-22
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2009-11-24
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2008-03-14
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2009-12-01
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2009-12-01
NOM	Antigen, Galactomannan, Aspergillus Spp.	Microbiology	Class 1	866.3040	2011-01-24
JKA	Tubes, Vials, Systems, Serum Separators, Blood Collection	Clinical Chemistry	Class 2	862.1675	2019-08-07
LCP	Assay, Glycosylated Hemoglobin	Hematology	Class 2	864.7470	2019-08-07
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	1989-08-14
LHJ	Staphylococcus Aureus Protein A Insoluble	Microbiology	Class 1	866.3700	1998-07-15
QKO	Reagent, Coronavirus Serological	Unknown	Class N	N/A	2020-05-15
QSU	Point Of Care Hiv Serology Diagnostic And/Or Supplemental Test	Microbiology	Class 2	866.3956	2025-09-04
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2007-06-06
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2025-04-17
LIP	Enzyme Linked Immunoabsorption Assay, Treponema Pallidum	Microbiology	Class 2	866.3830	2024-11-15
DHX	System, Test, Carcinoembryonic Antigen	Immunology	Class 2	866.6010	2024-11-15
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2024-11-15
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	1989-08-14
LOL	Hepatitis A Test (Antibody And Igm Antibody)	Microbiology	Class 2	866.3310	2007-06-06
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2024-11-15

Official Correspondent

No official correspondent registered.

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

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3002889627	BIO-RAD	MARNES-LA-COQUETTE Ile-de-France, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K873780	Labsystems, Inc.	MODIFICATION RUBELLA IGM EIA TEST KIT	1987-10-15
K872302	Ciba Corning Diagnostics Corp.	MODEL 550 EXPRESS CLINICAL CHEMISTRY ANALYZER	1987-09-08
K222850	Abbott Laboratories	HAVAb IgG II	2023-08-10
K081716	Siemens Healthcare Diagnostics, Inc.	ADVIA CENTAUR HAVM ASSAY	2008-07-17
K862389	Otisville Biotech, Inc.	BIOTIS ACETAMIDE AGAR	1986-07-03

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0011-2008	Pml Microbiologicals Inc.	2	Brain Heart Infusion Agar (BHIA) + Vancomycin 6 MCG/ML Microbiological media plates
Z-0014-2008	Pml Microbiologicals Inc.	2	Brain Heart Infusion Agar labeled BHIA + Vancomycin 6 MCG/ML For Screening for Vancomycin Resistant Enterococci PML microbiologicals Wilsonville, Oregon 97070 USA Catalog #P1174
Z-0081-2017	Siemens Healthcare Diagnostics, Inc.	2	SIEMENS IMMULITE/IMMULITE 1000 Systems Rubella IgM (RUM), REF/Catalog Number LKRM1 (OUS), Siemens Material Number (SMN) 10381282 (OUS), Unique Device Identification Number (UDI) 00630414964577; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age.
Z-0082-2017	Siemens Healthcare Diagnostics, Inc.	2	SIEMENS IMMULITE/IMMULITE 2000 Systems Rubella IgM (RUM), REF/Catalog Number for US: L2KRM2(D), Siemens Material Number (SMN) for US: 10374021, REF/Catalog # for OUS: L2KRM2, SMN for OUS: 10381327; Unique Device Identification Number (UDI) 00630414961996; IVD --- For in vitro diagnostic use with the IMMULITE/IMMULITE 1000/IMMULITE 2000/IMMULITE 2000 XPi Systems Analyzers-for the qualitative detection of IgM antibodies to Rubella virus in human serum or plasma (EDTA and heparinized), as an aid in the presumptive diagnosis of an acute or recent rubella infection, particularly in women of childbearing age
Z-0008-06	Abbott Laboratories, Inc	1	ARCHITECT c800 for Conventional Units and for SI Units, Version 5.00.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8023060. Last updated year: 2026. Please use registration number 8023060 when referencing this establishment in official correspondence.