Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

9615037

FEI Number

3003261083

Entity Name

BIOMERIEUX ITALIA-INDUSTRIAL DIV.

City/State/Country

PONTE-A EMA, FLORENCE Firenze, IT

Establishment Address

VIA DI CAMPIGLIANO 58, PONTE-A EMA, FLORENCE Firenze 50012, IT

Establishment Type(s)

Manufacture Medical 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 3 VITEK MS Prime VIDAS system VITEK Immunodiagnostic Assay System NucliSENS easyMAG Instrument eMAG Tips 1000 microliters eMAG Instrument EASYMAG DISPOSABLE 384T EMAG® V1.2 UPDATE INSTALLER DVD EASYMAG RP5810 W7 DVD MASTER V2.1 EMAG® RP5810 W7 DVD MASTER V1.2 EMAG® Software V1.3 easyMAG® Software V2.1 EMAG® Software V1.4

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DAP	Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	Hematology	Class 2	864.7320	2015-07-20
LGD	Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	Microbiology	Class 2	866.3780	2015-07-20
LFX	Enzyme Linked Immunoabsorbent Assay, Rubella	Microbiology	Class 2	866.3510	2015-07-20
LYR	Helicobacter Pylori	Microbiology	Class 1	866.3110	2015-07-20
JHI	Visual, Pregnancy Hcg, Prescription Use	Clinical Chemistry	Class 2	862.1155	2015-07-20
KLI	Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	Clinical Chemistry	Class 2	862.1700	2015-07-20
JLW	Radioimmunoassay, Thyroid-Stimulating Hormone	Clinical Chemistry	Class 2	862.1690	2015-07-20
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	Clinical Chemistry	Class 1	862.2160	2015-07-20
CDZ	Radioimmunoassay, Testosterones And Dihydrotestosterone	Clinical Chemistry	Class 1	862.1680	2015-07-20
LSR	Reagent, Borrelia Serological Reagent	Microbiology	Class 2	866.3830	2015-07-20
QBN	Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	Microbiology	Class 2	866.3378	2022-03-16
DEW	Igg, Antigen, Antiserum, Control	Immunology	Class 2	866.5510	2007-12-27
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2004-07-07

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
K151534	Instrumentation Laboratory CO	HemosIL D-Dimer HS	2015-07-06
K160885	Instrumentation Laboratory CO	HemosIL D-Dimer HS	2016-10-27
K954575	Abbott Laboratories	AXSYM TOXO IGG ANTIBODY ASSAY	1996-08-16
K032162	Beckman Coulter, Inc.	ACCESS IMMUNOASSAY SYSTEM TOXO IGG ASSAY	2003-08-08
K873780	Labsystems, Inc.	MODIFICATION RUBELLA IGM EIA TEST KIT	1987-10-15

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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-0006-05	Abbott Health Products, Inc.	2	AxSYM Total B-hCG Reagent, Product list number: 7A59-22 and 7A59-21
Z-0022-2025	Qualigen Inc	2	FastPack TSH Calibrator Kit, REF: 25000024, For use in conjunction with the FastPack IP TSH Immunoassay and FastPack IP System Analyzer
Z-0044-2020	Roche Diagnostics Operations, Inc.	2	AssayTip/AssayCup Tray-used on the cobas e 801 module which is a part of the cobas c 8000 MODULAR Analyzer Series (IVD for in vitro determination of analytes in human body fluids) Catalog Number: 5694302001

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 9615037. Last updated year: 2026. Please use registration number 9615037 when referencing this establishment in official correspondence.