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Biomerieux Italia-Industrial Div.: FDA-registered device maker in PONTE-A EMA, FLORENCE Firenze, Italy, 3 510(k) clearances

Name: Biomerieux Italia-Industrial Div. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Biomerieux Italia-Industrial Div. is registered with the FDA (registration 9615037) in PONTE-A EMA, FLORENCE Firenze, Italy. It lists 13 device types. The FDA files 3 510(k) clearances under its listings, the newest dated July 9, 2015. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 9615037
FEI number: 3003261083
Address: Via Di Campigliano 58, PONTE-A EMA, FLORENCE Firenze, Italy, 50012
Owner or operator: BIOMERIEUX SA (8020790)
Roles: Contract manufacturer, Manufacturer
First device listed: July 7, 2004
Registered through: 2027
Brand names listed: EASYMAG DISPOSABLE 384T, EASYMAG RP5810 W7 DVD MASTER V2.1, EMAG® RP5810 W7 DVD MASTER V1.2, EMAG® Software V1.3, EMAG® Software V1.4, EMAG® V1.2 UPDATE INSTALLER DVD, MiniVIDAS Instrument, NucliSENS easyMAG Instrument and more

Devices it lists

Device	Product code	Class	Role	Source
Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	JJE	1	Manufacturer	accessdata.fda.gov
Clinical Sample Concentrator	JJH	1	Manufacturer	accessdata.fda.gov
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine	KLI	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Rubella	LFX	2	Manufacturer	accessdata.fda.gov
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii	LGD	2	Manufacturer	accessdata.fda.gov
Fibrinogen And Fibrin Split Products, Antigen, Antiserum, Control	DAP	2	Manufacturer	accessdata.fda.gov
Helicobacter Pylori	LYR	1	Manufacturer	accessdata.fda.gov
Igg, Antigen, Antiserum, Control	DEW	2	Manufacturer	accessdata.fda.gov
Mass Spectrometry, Maldi Tof, Microorganism Identification, Cultured Isolates	QBN	2	Contract manufacturer	accessdata.fda.gov
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1	Manufacturer	accessdata.fda.gov
Radioimmunoassay, Thyroid-Stimulating Hormone	JLW	2	Manufacturer	accessdata.fda.gov
Reagent, Borrelia Serological Reagent	LSR	2	Manufacturer	accessdata.fda.gov
Visual, Pregnancy Hcg, Prescription Use	JHI	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
July 9, 2015	K141133	VIDAS H. pylori IgG, VIDAS 3, VIDAS Lyme IgG II, VIDAS RUB IgG, VIDAS TOXO M, VIDAS Human Chorionic Gonadotropin, VIDAS T4, VIDAS Testosterone, VIDAS TSH, and VIDAS D-Dimer Exclusion II	LYR	Substantially Equivalent	BIOMERIEUX	accessdata.fda.gov
February 12, 1993	K923579	MINIVIDAS INSTRUMENT	JJE	Substantially Equivalent	Biomerieux Vitek, Inc.	accessdata.fda.gov
April 18, 1989	K891385	VITEK IMMUNODIAGNOSTIC ASSAY SYSTEM (VIDAS)	DEW	Substantially Equivalent	Vitek Systems, Inc.	accessdata.fda.gov

Compare with other makers

Updated July 9, 2015. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.