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WELLlife™

WONDFO USA CO., LTD. · Model WCOV-OTC-N2 · UDI-DI 00810174471243

QYT
1
510(k) clearances
142
Adverse events
3
Recalls
24
Facilities

Description

WELLlife™ COVID-19 Antigen Home Test Cassette, New Package 2 Tests per Kitbox with Holder

Recalls

DateFirmReason
2024-06-26FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTDThe "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
2024-06-26FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTDThe "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.
2024-06-26FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTDThe "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.