Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

8020790

FEI Number

1000611339

Entity Name

BIOMERIEUX SA

City/State/Country

MARCY L ETOILE Rhone, FR

Establishment Address

CHEMIN DE L ORME, MARCY L ETOILE Rhone 69280, FR

Establishment Type(s)

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

Owner / Operator

BIOMERIEUX SA (Owner Number: 8020790)

Owner / Operator Contact Address

Chemin De L Orme, Marcy L Etoile, FR-69 69280, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

VIDAS TOXO IgG Avidity VIDAS B.R.A.H.M.S PCT easySTREAM Instrument PreviISOLA VIDAS 3 ASSAY DILUTION CUP VIDAS 3 SAMPLE TIP Dry Blood Spot Puncher VIDAS® NEPHROCHECK® VIDAS RUB IGG VIDAS VZG IGG Assay QCV - Quality Control VIDAS VIDAS CDA/B Assay VIDAS Lyme IgG SLIDEX STREPTO VIDAS B.R.A.H.M.S PCT VIDAS MEASLES IGG ASSAY ENZYME LINKED IMMUNOA VIDAS CMV IGM Assay VIDAS D-DIMER Exclusion II VIDAS TOXO IGG II (TXG) Assay MODEL (TSH) VIDAS Thyroid Stimulating Hormone Free Diluent VIDAS CMV IGG Assay VIDAS® Lyme IgM VIDAS Mumps (IgG) (MPG) Assay APIWeb MYLA VIDAS® C. difficile GDH VIDAS PROGESTERONE (PRG) VIDAS Estradiol II (E2II) Assay VIDAS H. Pylori IGG (HPY) Assay, MO VIDAS TBI (GFAP, UCH-L1) VIDAS Toxoplasma Gondii IGM Assay VIDAS B.R.A.H.M.S. PCT (PCT) VIDAS Luteinizing Hormone Assay kit RAL Stainer Fluo RAL kit RAL Stainer Cold ZN PREVI FLUO TB

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2011-06-01
NTM	Antigen, Inflammatory Response Marker, Sepsis	Microbiology	Class 2	866.3210	2007-12-11
JQW	Station, Pipetting And Diluting, For Clinical Use	Clinical Chemistry	Class 1	862.2750	2015-07-30
LXG	Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	Clinical Chemistry	Class 1	862.2050	2011-01-16
PIG	Acute Kidney Injury Test System	Clinical Chemistry	Class 2	862.1220	2022-07-12
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2009-01-08
LFY	Enzyme Linked Immunoabsorbent Assay, Varicella-Zoster	Microbiology	Class 2	866.3900	2007-12-06
OHQ	Multi-Analyte Controls Unassayed	Clinical Chemistry	Class 1	862.1660	2018-07-17
LLH	Reagents, Clostridium Difficile Toxin	Microbiology	Class 1	866.2660	2009-02-04
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2013-03-15
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2004-08-24
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2016-07-21
LJB	Enzyme Linked Immunoabsorbent Assay, Rubeola Igg	Microbiology	Class 1	866.3520	1999-05-26
LKQ	Antibody Igm,If, Cytomegalovirus Virus	Microbiology	Class 2	866.3175	2007-12-06
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2012-08-20
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2007-12-06
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2007-12-06
JFT	Fluorometric, Cortisol	Clinical Chemistry	Class 2	862.1205	2007-12-31
LFZ	Enzyme Linked Immunoabsorbent Assay, Cytomegalovirus	Microbiology	Class 2	866.3175	2007-12-06
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2013-12-04
LJY	Enzyme Linked Immunoabsorbent Assay, Mumps Virus	Microbiology	Class 1	866.3380	2007-12-06
OUG	Medical Device Data System	General Hospital	Class 1	880.6310	2014-11-17
MCB	Antigen, C. Difficile	Microbiology	Class 1	866.2660	2013-12-04
JLS	Radioimmunoassay, Progesterone	Clinical Chemistry	Class 1	862.1620	2007-12-10
CHP	Radioimmunoassay, Estradiol	Clinical Chemistry	Class 1	862.1260	2007-12-10
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2007-12-06
QAT	Brain Trauma Assessment Test	Immunology	Class 2	866.5830	2024-05-07
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2007-12-06
PMT	Device To Detect And Measure Procalcitonin (Pct) In Human Clinical Specimens	Microbiology	Class 2	866.3215	2017-02-27
PRI	Procalcitonin Assay	Microbiology	Class 2	866.3215	2017-02-27
NTM	Antigen, Inflammatory Response Marker, Sepsis	Microbiology	Class 2	866.3210	2017-02-27
CEP	Radioimmunoassay, Luteinizing Hormone	Clinical Chemistry	Class 1	862.1485	2007-12-10
LEE	Stains, Dye Solution	Hematology	Class 1	864.1850	2012-03-16

Official Correspondent

No official correspondent registered.

US Agent Details

Nathan Hardesty Business: BioMerieux, SA Email: nathan.hardesty@biomerieux.com Phone: (314) 7318666

Related Public Records

Same Entity

BIOMERIEUX SA

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
1450405	BIOMERIEUX, INC.	LOMBARD, IL, US
3023036790	Specific Diagnostics	San Jose, CA, US
3025775667	BIOMERIEUX, INC.	Salt Lake City, UT, US
3008249922	BIOMERIEUX SA - Grenoble	Grenoble Cedex 01 Auvergne-Rhone-Alpes, FR
3009307598	BIOMERIEUX SPAIN	Tres Cantos Madrid (Province), ES

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K954575	Abbott Laboratories	AXSYM TOXO IGG ANTIBODY ASSAY	1996-08-16
K032162	Beckman Coulter, Inc.	ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY	2003-08-08
K851403	Ventrex Laboratories, Inc.	VENTREZYME ALLERGEN DATA REDUCTION SYSTEM	1985-06-21
K761290	Nuclear Medical Laboratories, Inc.	COMPU-PET 300	1977-02-24
K770210	G.D. Searle and Co.	ANALYTIX AUTO SAMPLE PREP. STA. 1600	1977-02-14

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0002-2013	Beckman Coulter Inc.	1	COULTER PrepPlus, Part Number: 286600 Product Usage: The COULTER PrepPlus, is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0028-2012	Beckman Coulter Inc.	1	Coulter PrepPlus 2, Part Number: 378600, Serial Numbers: 1001008698, 1001008699, and 10018700. Coulter PrePlus 2 is a microprocessor-controlled pipetting and diluting system, designed for automating sample preparation or assay methods. It is capable of aspirating and dispensing liquid samples.
Z-0002-2008	Beckman Coulter Inc	1	FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013	Biomerieux Inc	1	PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.
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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8020790. Last updated year: 2026. Please use registration number 8020790 when referencing this establishment in official correspondence.