Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003232042

FEI Number

3003232042

Entity Name

ORGENTEC DIAGNOSTIKA GMBH

City/State/Country

MAINZ Rhineland-Palatinate, DE

Establishment Address

CARL-ZEISS-STRASSE 49-51, MAINZ Rhineland-Palatinate 55129, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Corgenix Inc. (Owner Number: 9022938)

Owner / Operator Contact Address

11575 Main St, Suite 400, Broomfield, CO 80020, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K092399

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
OQZ	Anti-Mutated Citrullinated Vimentin Igg	Immunology	Class 2	866.5775	2010-12-23

Official Correspondent

No official correspondent registered.

US Agent Details

Souda Truong Business: Corgenix Inc Email: Struong@corgenix.com Phone: (303) 4574345

Related Public Records

Same Entity

Corgenix Inc.

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 3003232042. Last updated year: 2026. Please use registration number 3003232042 when referencing this establishment in official correspondence.