Home › Device types › QYT
Over-The-Counter Covid-19 Antigen Test
FDA product code QYT · Class 2 · Microbiology
54
Registered devices
142
Adverse events
3
Recalls
14
510(k) clearances
Devices with this code
COVID-19 Detect™ Rapid Self -Test — INBIOS INTERNATIONAL, INCCareSuperb COVID-19 Antigen Home Test — Access Bio Inc.WELLlife™ — WONDFO USA CO., LTD.CVS Health At Home COVID-19 Test Kit — DIAGNOSTIC HYBRIDS, INC.WELLlife™ — WONDFO USA CO., LTD.CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box — WatMIND USACASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box — WatMIND USAGenaCheck® COVID-19 Rapid Self-Test 4T — Genabio Diagnostics Inc.WELLlife™ — WONDFO USA CO., LTD.CorDx Tyfast — CORETESTS, INC.GenaCheck® COVID-19 Rapid Self-Test 20T — Genabio Diagnostics Inc.CorDx Tyfast — CORETESTS, INC.CVS Health At Home COVID-19 Test Kit — DIAGNOSTIC HYBRIDS, INC.Flowflex COVID-19 Antigen Home Test — Acon Laboratories, Inc.equate — WAL-MART STORES, INC.SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 4 Tests/Box — WatMIND USAiHealth — iHealth Labs Inc.Retail Display Box - SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tes — WatMIND USAequate — WAL-MART STORES, INC.WELLlife™ — WONDFO USA CO., LTD.WELLlife™ — WONDFO USA CO., LTD.CorDx Tyfast — CORETESTS, INC.CareSuperb COVID-19 Antigen Home Test — Access Bio Inc.WELLlife™ — WONDFO USA CO., LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-06-26 | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD | The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States. |
| 2024-06-26 | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD | The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States. |
| 2024-06-26 | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD | The "DVOT brand" rapid test kits have not obtained the necessary authorization to be sold in the United States. |
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