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FDA 510(k)

WELLlife COVID-19 Antigen Test Rx

K-Number: K251289 · 2025-10-22

ApplicantGuangzhou Wondfo Biotech Co., Ltd.
Decision Date2025-10-22
Product CodeQVF
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

WELLlife COVID-19 Antigen Test Rx is a medical device manufactured by Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-22 under approval number K251289. The device is classified under product code QVF. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WELLlife COVID-19 Antigen Test Rx?

WELLlife COVID-19 Antigen Test Rx is a medical device that received FDA 510(k) clearance on 2025-10-22. It is manufactured by Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K251289.

When was WELLlife COVID-19 Antigen Test Rx approved by the FDA?

WELLlife COVID-19 Antigen Test Rx received FDA 510(k) clearance on 2025-10-22, under approval number K251289.

What company makes WELLlife COVID-19 Antigen Test Rx?

WELLlife COVID-19 Antigen Test Rx is manufactured by Guangzhou Wondfo Biotech Co., Ltd..

What is the FDA product code for WELLlife COVID-19 Antigen Test Rx?

The FDA product code for WELLlife COVID-19 Antigen Test Rx is QVF.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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