Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012104694

FEI Number

3012104694

Entity Name

EUROFINS GENOMICS LLC

City/State/Country

Louisville, KY, US

Establishment Address

12621 Plantside Dr, Louisville, KY 40299, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Eurofins Genomics LLC (Owner Number: 10042220)

Owner / Operator Contact Address

12621 Plantside Drive, Louisville, KY 40299, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MVU	Reagents, Specific, Analyte	Pathology	Class 1	864.4020	2012-11-01

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Eurofins Genomics LLC

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

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
1124976	SUPERTECHS, INC.	Gaithersburg, MD, US
3011873748	AUGUREX LIFE SCIENCES CORP	Vancouver British Columbia, CA
3013059683	ATSI Logistics Center ApS	GLOSTRUP Hovedstaden, DK
3004375571	GLYCOMINDS DIAGNOSTICS (2014) LTD.	Raanana Central, IL
3027518847	Phase Scientific (Shenzhen) Company Limited	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012104694. Last updated year: 2026. Please use registration number 3012104694 when referencing this establishment in official correspondence.