Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014290238

FEI Number

3014290238

Entity Name

OMEGA BIO-TEK

City/State/Country

Norcross, GA, US

Establishment Address

400 Pinnacle Way #450, Norcross, GA 30071, US

Establishment Type(s)

Manufacture Device in the United States for Export Only

Owner / Operator

Omega Bio-Tek (Owner Number: 10090841)

Owner / Operator Contact Address

400 Pinnacle Way #450, Norcross, GA 30071, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

MBFit24 cfDNA Kit CE IVD Mag-Bind® Blood DNA HV Kit CE IVD MBFit24 Blood & Tissue DNA Kit CE IVD Mag-Bind® Blood & Tissue DNA Kit CE IVD Mag-Bind® Viral DNA/RNA Xpress Kit CE IVD MagBinder Fit24 Mag-Bind® cfDNA Kit CE IVD

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJH	Clinical Sample Concentrator	Clinical Chemistry	Class 1	862.2310	2024-05-21

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Omega Bio-Tek

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 3014290238. Last updated year: 2026. Please use registration number 3014290238 when referencing this establishment in official correspondence.