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CVS Health At Home COVID-19 Test Kit

DIAGNOSTIC HYBRIDS, INC. · Model 20452 · UDI-DI 00050428101735

QYT
10
510(k) clearances
138
Adverse events
3
Recalls
24
Facilities

Description

CVS Health At Home COVID-19 Test Kit

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.