Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003652672

FEI Number

3003652672

Entity Name

BioReference Health, LLC

City/State/Country

Elmwood Park, NJ, US

Establishment Address

481 Edward H. Ross Drive, Elmwood Park, NJ 07407, US

Establishment Type(s)

Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198

Owner / Operator

OPKO Health, Inc. (Owner Number: 10059750)

Owner / Operator Contact Address

4400 Biscayne Boulevard, Miami, FL 33137, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

P190022

All Registered Proprietary Names

4Kscore Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QRF	Multi-Analyte Test System With Algorithmic Analysis For Detection Of Prostate Cancer	Unknown	Class 3	N/A	2022-01-13

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

OPKO Health, Inc.

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

View Entity Profile →

Similar Registrations

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3009999323	STORE-ALL LOGISTICS LTD	Slieverue Kilkenny, IE
3008478369	FERROSAN MEDICAL DEVICES A/S	Soeborg Hovedstaden, DK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003652672. Last updated year: 2026. Please use registration number 3003652672 when referencing this establishment in official correspondence.