WELLlife COVID-19 Antigen Test Rx
FDA 510(k) K251289 · Guangzhou Wondfo Biotech Co., Ltd.
Submission
- Device name
- WELLlife COVID-19 Antigen Test Rx
- Applicant
- Guangzhou Wondfo Biotech Co., Ltd.
Guangzhou, CN - Received
- April 25, 2025
- Decision date
- October 22, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Dual Track 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QVF – Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.3982
- Specialty
- Microbiology
A simple point-of-care device to detect SARS-CoV-2 viral targets directly from clinical specimens in near-patient settings is an in vitro diagnostic device for the direct detection of SARS-CoV-2 in clinical specimens and is intended as an aid in the diagnosis of SARS-CoV-2 infections COVID-19). The device is simple to use and does not involve sample manipulation, transportation of the sample to…
Other 510(k)s with product code QVF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254264 | Sofia 2 SARS Antigen+ FIA; Sofia 2 Lyme FIAQVF · Dual Track | Ortho-Clinical Diagnostics, Inc. (QuidelOrtho) | 09/04/2026SE |
| K253882 | CorDx Tyfast COVID-19 Ag Rapid Test RxQVF · Dual Track | CorDx, Inc. | 06/01/2026SE |
| K243872 | BD Veritor System for SARS-CoV-2QVF · Dual Track | Becton, Dickinson and Company | 06/16/2025SE |
| K250273 | BinaxNOW COVID-19 Ag CardQVF · Dual Track | Abbott Diagnostics Scarborough, Inc. | 06/13/2025SE |
| K233358 | SCoV-2 Ag Detect Rapid TestQVF · Dual Track | InBios International, Inc. | 08/23/2024SE |
| K232377 | Healgen Rapid COVID-19 Antigen TestQVF · Traditional | Healgen Scientific,, LLC | 04/19/2024SE |
| K231187 | Nano-Check COVID-19 Antigen TestQVF · Traditional | Nano-Ditech Corporation | 01/23/2024SE |
| K233688 | Sofia 2 SARS Antigen+ FIA; Sofia 2 SARS Antigen+ FIA Control Swab SetQVF · Special | Quidel Corporation | 12/13/2023SE |
More from Quidel Corporation
| 510(k) | Device | Decision |
|---|---|---|
| K260065 | SAFElife T-Dip Multi-Drug Urine Test Panel; SAFElife T-Dip Multi-Drug Urine Test Panel DxNFT · Traditional | 04/28/2026SE |
| K252550 | SAFElife T-Cup Multi-Drug Urine Test Cup; SAFElife T-Cup Multi-Drug Urine Test Cup DxNFT · Traditional | 11/18/2025SE |
| K241317 | Wondfo 2019-nCoV Antigen Test (Lateral Flow Method)QYT · Traditional | 09/30/2024SE |
| K241741 | SAFElife Fentanyl Urine Home Test (Cassette); SAFElife Fentanyl (FTY) Urine Test…NGL · Traditional | 07/16/2024SE |
| K202567 | Wondfo T-Dip Multi-Drug Urine Test Panel, Wondfo T-Dip Multi-Drug Urine Test Panel RxNFT · Traditional | 09/25/2020SE |
| K182701 | Wondfo T-Cup Multi-Drug Urine Test CupNFT · Traditional | 12/03/2018SE |
| K173229 | Preview Digital Pregnancy TestLCX · Traditional | 03/12/2018SE |
| K162333 | Wondfo One Step Fecal Occult Blood (FOB) TestKHE · Traditional | 05/14/2017SE |
| K161214 | Wondfo Amphetamine Urine Test AMP 500 (Cup, Dipcard), Wondfo Cocaine Urine Test COC…DIO · Traditional | 06/27/2016SE |
| K152495 | Wondfo Propoxyphene Urine TestJXN · Traditional | 11/23/2015SE |
Questions and answers
When was WELLlife COVID-19 Antigen Test Rx cleared by the FDA?
WELLlife COVID-19 Antigen Test Rx (K251289) received a 510(k) decision of Substantially Equivalent on October 22, 2025, 180 days after the submission was received.
What is the product code of K251289?
The FDA product code is QVF – Simple Point-Of-Care Device To Directly Detect Sars-Cov-2 Viral Targets From Clinical Specimens In Near-Patient Settings, a Class II (moderate risk) device regulated under 21 CFR 866.3982.