Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016252795

FEI Number

3016252795

Entity Name

Wondfo USA Co., Ltd.

City/State/Country

San Diego, CA, US

Establishment Address

6720 Cobra Way, San Diego, CA 92121, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

Wondfo USA Co., Ltd. (Owner Number: 10028951)

Owner / Operator Contact Address

890 REMINGTON BLVD, Bolingbrook, IL 60440, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K251563

PMA Number

N/A

All Registered Proprietary Names

WELLlife COVID-19 / Influenza A&B Test WELLlife COVID-19 / Influenza A&B Home Test Toptolife Strep A Test Preview® Strep A Test Kit WELLlife COVID-19 Antigen Test Rx Control Kit WELLlife Influenza A&B Test Control Kit WELLlife COVID-19 / Influenza A&B Antigen Test Control Kit QuickVue Influenza+SARS Test Control Kit INDICAID COVID-19 / INFLUENZA A&B ANTIGEN TEST CONTROL KIT WELLlife Flu A&B Home Test WELLlife Influenza A&B Test MEDLINE Flu A & B Rapid Antigen Cassette Test

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QMN	Covid-19 Multi-Analyte Antigen Device	Unknown	Class N	N/A	2024-05-14
GTY	Antigens, All Groups, Streptococcus Spp.	Microbiology	Class 1	866.3740	2018-05-05
MJZ	Kit, Direct Antigen, Positive Control	Clinical Chemistry	Class 1	862.1660	2025-09-10
SCA	Multi-Analyte Respiratory Virus Antigen Detection Test	Microbiology	Class 2	866.3987	2025-09-10

Official Correspondent

Kunyuan Mao

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Wondfo USA Co., Ltd.

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3007606081	WONDFO USA CO., LTD.	Bolingbrook, IL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K133343	Guangzhou Wondfo Biotech Co., Ltd.	WONDFO RAPID STREP A TEST	2014-01-31

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016252795. Last updated year: 2026. Please use registration number 3016252795 when referencing this establishment in official correspondence.