Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

1450405

FEI Number

1450405

Entity Name

BIOMERIEUX, INC.

City/State/Country

LOMBARD, IL, US

Establishment Address

1105 N Main St, LOMBARD, IL 60148, US

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

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

TRYPCASE SOYA BROTH 20TUBES OEM Microscan Broth

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JSG	Culture Media, Non-Selective And Non-Differential	Microbiology	Class 1	866.2300	2000-08-30

Official Correspondent

No official correspondent registered.

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
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
9615778	BioMerieux SA	VERNIOLLE Ariege, FR

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880142	Hardy Media	TSA W/LEC. & TWEEN. 80	1988-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0032-06	BIOMERIEUX, INC.	2	VeriCal Calibrator Set

Similar Registrations

Registration Number	Establishment Name	Location
3017170972	SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD.	Shenzhen Guangdong, CN
9615755	BIOMERIEUX FRANCE	CRAPONNE Rhone, FR
1054241	DeRoyal Industries, Inc.	NEW TAZEWELL, TN, US
1930987	LABONE, INC.	LENEXA, KS, US
3009302820	WUXI NEST BIOTECHNOLOGY CO., LTD	Wuxi Jiangsu, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1450405. Last updated year: 2026. Please use registration number 1450405 when referencing this establishment in official correspondence.