Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3043140667

FEI Number

3043140667

Entity Name

GENESEEQ MEDICAL DEVICE AND DIAGNOSTIC INC.

City/State/Country

Nanjing Jiangsu, CN

Establishment Address

128 Huakang Road, Jiangbei New Area, Nanjing Jiangsu 210000, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Geneseeq Medical Device and Diagnostic Inc. (Owner Number: 10094752)

Owner / Operator Contact Address

128 Huakang Road, Jiangbei New Area, Nanjing, CN-JS 210000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GENESEEQPRIME NGS Tumor Profiling Assay (FFPE)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PZM	Next Generation Sequencing Based Tumor Profiling Test	Pathology	Class 2	866.6080	2025-12-20

Official Correspondent

Yedan Chen

US Agent Details

Scott Bednar Business: QA/RA CONSULTING GROUP, INC. Email: sbednar@qaraconsultinggroup.com Phone: (412) 4188066

Related Public Records

Same Entity

Geneseeq Medical Device and Diagnostic Inc.

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

View Entity Profile →

Similar Registrations

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3011805506	PERSONAL GENOME DIAGNOSTICS INC.	Baltimore, MD, US
3003335080	Life Technologies Corporation	FREDERICK, MD, US
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3043140667. Last updated year: 2026. Please use registration number 3043140667 when referencing this establishment in official correspondence.