Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025775667

FEI Number

3025775667

Entity Name

BIOMERIEUX, INC.

City/State/Country

Salt Lake City, UT, US

Establishment Address

1201 S 4800 W, Salt Lake City, UT 84104, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198

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

N50510

All Registered Proprietary Names

VITEK 2 GP Amoxicillin for S pneumo VITEK 2 GP Cefoxitin Screen VITEK 2 AST-GN Levofloxacin VITEK 2 AST-GP Penicillin G VITEK 2 AST-GP Streptomycin, HL VITEK 2 AST-GP Clindamycin VITEK 2 AST-GN Imipenem VITEK 2 AST-GN Tobramycin VITEK 2 AST-GP Ciprofloxacin VITEK 2 AST-GN Cefazolin VITEK 2 AST-GP Erythromycin VITEK 2 AST-GP Gentamicin, HL VITEK 2 AST-GN Cefpodoxime VITEK 2 AST-GP for S.pn Penicillin G VITEK 2 AST-GN Tetracycline VITEK 2 AST-GP for S.pn Ofloxacin VITEK 2 AST-GN Cefalotin VITEK 2 AST-GP Levofloxacin VITEK 2 AST-GN Cefuroxime VITEK 2 AST-GP Rifampin VITEK 2 AST-GN Meropenem VITEK 2 AST-GN Ceftriaxone VITEK 2 AST-GP Sparfloxacin VITEK 2 AST-GN Gentamicin VITEK 2 AST-GN Ampicillin VITEK 2 AST-GP Gentamicin VITEK 2 AST-GP for S.pn Tetracycline VITEK 2 Antimicrobial Susceptibility Test Device (GN, GP, and GP for S.pn) VITEK 2 AST-GN Ticarcillin/ Clavulanic Acid VITEK 2 AST-GP for S.pn Chloramphenicol VITEK 2 AST-GP Amp/Sulbactam VITEK 2 AST-GN Nitrofurantoin VITEK 2 AST-GN Amox/Clav VITEK 2 AST-GN Nalidixic Acid VITEK 2 AST-GN Ciprofloxacin VITEK 2 AST-GP for S.pn Cefotaxime VITEK 2 AST-GN Amp/Sulbactam VITEK 2 AST-GN Piperacillin VITEK 2 AST-GP Cefazolin VITEK 2 AST-GN Ticarcillin VITEK 2 AST-GN Cefoxitin VITEK 2 AST-GP for S.pn Trimeth./sulfa VITEK 2 AST-GN Pip/Tazob. VITEK 2 AST-GP Chloramphenicol VITEK 2 AST-GN Amikacin VITEK 2 AST-GN Norfloxacin VITEK 2 AST-GP Norfloxacin VITEK 2 AST-GN Cefepime VITEK 2 AST-GN Trimeth./sulfa VITEK 2 AST-GP Nitrofurantoin VITEK 2 AST-GP Ofloxacin VITEK 2 AST-GN Ceftazidime VITEK 2 AST-GP for S.pn Vancomycin VITEK 2 AST-GP Minocycline VITEK 2 AST-GN Cefotaxime VITEK 2 AST-GN Aztreonam VITEK 2 AST-GN Cefotetan VITEK 2 AST-GP for S.pn Ceftriaxone VITEK 2 AST-GN Ceftizoxime VITEK 2 AST-GP Vancomycin VITEK 2 AST-GP Tetracycline VITEK 2 AST-GP Ampicillin VITEK 2 AST-GP Oxacillin

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-06
LTW	Susceptibility Test Cards, Antimicrobial	Microbiology	Class 2	866.1640	2007-12-06
LON	System, Test, Automated, Antimicrobial Susceptibility, Short Incubation	Microbiology	Class 2	866.1645	2007-12-06

Official Correspondent

Nathan Hardesty

US Agent Details

No US Agent registered (Local establishment).

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
3008249922	BIOMERIEUX SA - Grenoble	Grenoble Cedex 01 Auvergne-Rhone-Alpes, FR
3009307598	BIOMERIEUX SPAIN	Tres Cantos Madrid (Province), ES
9615778	BioMerieux SA	VERNIOLLE Ariege, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K033458	Becton, Dickinson & CO	BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CONFIRMATORY ESBL TEST	2004-05-28
K112000	bioMerieux, Inc.	VITEK 2 STREPTOCOCCUS PENICILLIN	2011-10-26

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set
Z-0170-2015	Siemens Healthcare Diagnostics, Inc.	2	Rapid Neg BP Combo Panel Type 3; Catalog number B 1017-117. MicroScan Rapid panels are designed for use in determining identification to the species level and/or antimicrobial agent susceptibility of rapidly growing aerobic and facultatively anaerobic gram negative bacilli.

Similar Registrations

Registration Number	Establishment Name	Location
3013718871	UPS Supply Chain Solutions, Inc.	Pedricktown, NJ, US
1119779	BECTON, DICKINSON & CO.	SPARKS, MD, US
3031977134	bioMerieux, Inc.	Morrisville, NC, US
1950204	BIOMERIEUX, INC.	HAZELWOOD, MO, US
3007502289	Laboratorios PiSA, S. A. de C.V.	Tlajomulco de Zuniga Jalisco, MX

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025775667. Last updated year: 2026. Please use registration number 3025775667 when referencing this establishment in official correspondence.