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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 the device name listed in this FDA 510(k) record. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2025-10-22 under 510(k) 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. The listed applicant is Guangzhou Wondfo Biotech Co., Ltd.. The 510(k) number is K251289.

When did WELLlife COVID-19 Antigen Test Rx receive FDA 510(k) clearance?

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

Who is the listed applicant for WELLlife COVID-19 Antigen Test Rx?

The FDA 510(k) record lists Guangzhou Wondfo Biotech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Guangzhou Wondfo Biotech Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: QVF)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253882CorDx Tyfast COVID-19 Ag Rapid Test RxCorDx, Inc.K243872BD Veritor System for SARS-CoV-2Becton, Dickinson and CompanyK250273BinaxNOW COVID-19 Ag CardAbbott Diagnostics Scarborough, Inc.K233358SCoV-2 Ag Detect Rapid TestInBios International, Inc.K232377Healgen Rapid COVID-19 Antigen TestHealgen Scientific,, LLCK231187Nano-Check™ COVID-19 Antigen TestNano-Ditech Corporation

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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