Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014660585

FEI Number

3014660585

Entity Name

GENBODY INC.

City/State/Country

Cheonan Chungnam, KR

Establishment Address

3-18, 3-12, Eopseong 2-gil, Cheonan-si, Cheonan Chungnam 31077, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

GenBody Inc. (Owner Number: 10067610)

Owner / Operator Contact Address

3-18, Eopseong 2-gil, Cheonan-si, Cheonan-si, KR-44 31077, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Genbody COVID-19 Ag GenBody COVID-19 Ag Home Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QKP	Coronavirus Antigen Detection Test System.	Unknown	Class N	N/A	2021-03-30

Official Correspondent

No official correspondent registered.

US Agent Details

Paul Kwon Business: Kwell Laboratories Inc. Email: paul@kwelllabs.com Phone: (949) 5610664

Related Public Records

Same Entity

GenBody Inc.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0001-2023	Jiangsu Well Biotech Co., Ltd. No	N	Jiangsu Well Biotech Co.,Ltd. AND SDI LABS COVID-19 Ag Rapid Test Device - Cat#: CO-02

Similar Registrations

Registration Number	Establishment Name	Location
3043128348	Shenzhen Yang Biotech Co., Ltd.	Shenzhen Guangdong, CN
9610126	ROCHE DIAGNOSTICS GMBH	MANNHEIM Baden-Wurttemberg, DE
3008054239	CORE TECHNOLOGY CO., LTD.	Changping District Beijing, CN
3016761091	Shenzhen Watmind Medical Co., Ltd.	Shenzhen Guangdong, CN
3002642396	Ortho Clinical Diagnostics	Singapore South West, SG

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014660585. Last updated year: 2026. Please use registration number 3014660585 when referencing this establishment in official correspondence.