GENBODY AMERICA, LLC

FDA Device Registration & Listing · Jurupa Valley, CA, US · Registration 3020964039

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3020964039
FEI Number
3020964039
Entity Name
GENBODY AMERICA, LLC
City/State/Country
Jurupa Valley, CA, US
Establishment Address
3420 De Forest Cir., Jurupa Valley, CA 91752, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Genbody America, LLC (Owner Number: 10082202)
Owner / Operator Contact Address
3420 De Forest Circle, Jurupa Valley, CA 91752, US
Initial Importer Flag
Y
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 2022-01-25

Official Correspondent

Paul Kwon

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Genbody America, LLC
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

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020964039. Last updated year: 2026. Please use registration number 3020964039 when referencing this establishment in official correspondence.
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