Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3007261225

FEI Number

3007261225

Entity Name

GENE BY GENE

City/State/Country

Houston, TX, US

Establishment Address

1445 N Loop W Suite 820, Houston, TX 77008, US

Establishment Type(s)

Repack or Relabel Medical Device,Manufacture Medical Device

Owner / Operator

Gene by Gene (Owner Number: 10090751)

Owner / Operator Contact Address

1445 N Loop W Suite 820, Houston, TX 77008, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

NucleoShield

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
NNK	Container, Specimen Mailer And Storage, Non-Sterile	Pathology	Class 1	864.3250	2024-05-17

Official Correspondent

Feng Zhou

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Gene by Gene

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 3007261225. Last updated year: 2026. Please use registration number 3007261225 when referencing this establishment in official correspondence.