Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3011310310

FEI Number

3011310310

Entity Name

INTEGEN LLC

City/State/Country

Orlando, FL, US

Establishment Address

8865 Commodity Cir Ste 2, Orlando, FL 32819, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

InteGen LLC (Owner Number: 10048163)

Owner / Operator Contact Address

8865 Commodity Circle, Suite 2, Orlando, FL 32819, 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	2014-12-12

Official Correspondent

Ramesh Vallabhaneni

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

InteGen LLC

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3011310310. Last updated year: 2026. Please use registration number 3011310310 when referencing this establishment in official correspondence.