Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009469260

FEI Number

3009469260

Entity Name

BIOREX LABS LLC

City/State/Country

Broadview Heights, OH, US

Establishment Address

8041 Broadview Rd, Broadview Heights, OH 44147, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Biorex Labs LLC (Owner Number: 10040313)

Owner / Operator Contact Address

8041 BROADVIEW ROAD, Broadview Heights, OH 44147, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

K-CHECK DIAZO-CHEK

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2015-02-03
JJB	Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1115	2013-07-16

Official Correspondent

Evelyn Mirza

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Biorex Labs 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 3009469260. Last updated year: 2026. Please use registration number 3009469260 when referencing this establishment in official correspondence.