Home › Device types › QYT
Over-The-Counter Covid-19 Antigen Test
FDA product code QYT · Class 2 · Microbiology
44
Registered devices
138
Adverse events
3
Recalls
14
510(k) clearances
Devices with this code
CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box — WatMIND USAGenaCheck® COVID-19 Rapid Self-Test 20T — Genabio Diagnostics Inc.Flowflex COVID-19 Antigen Home Test — Acon Laboratories, Inc.BinaxNOW COVID-19 Antigen Self Test — Alere Scarborough, Inc.WELLlife™ — WONDFO USA CO., LTD.Retail Display Box - SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tes — WatMIND USARetail Display Box - SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Tes — WatMIND USABinaxNOW COVID-19 Antigen Self Test — Alere Scarborough, Inc.equate — WAL-MART STORES, INC.GenaCheck® COVID-19 Rapid Self-Test 4T — Genabio Diagnostics Inc.Speedy Swab Rapid COVID-19 & FLU A+B Self-Test (1 Test/Box) — WatMIND USACareSuperb COVID-19 Antigen Home Test — Access Bio Inc.CareSuperb COVID-19 Antigen Home Test — Access Bio Inc.WELLlife™ — WONDFO USA CO., LTD.CorDx Tyfast — CORETESTS, INC.CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 1 Test/Box — WatMIND USABinaxNOW COVID-19 Antigen Self Test — Alere Scarborough, Inc.WELLlife™ — WONDFO USA CO., LTD.CorDx Tyfast — CORETESTS, INC.COVID-19 Detect™ Rapid Self -Test — INBIOS INTERNATIONAL, INCCVS Health At Home COVID-19 Test Kit — DIAGNOSTIC HYBRIDS, INC.CASE SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 4 Tests/Box — WatMIND USAWELLlife™ — WONDFO USA CO., LTD.CASE-RDB-SpeedySwab Rapid COVID_19 + Flu A&B Antigen Self-Test 2 Tests/Box — WatMIND USA
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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