Home › Alere Scarborough, Inc. › BinaxNOW COVID-19 Antigen Self Test
BinaxNOW COVID-19 Antigen Self Test
Alere Scarborough, Inc. · Model 195-170 · UDI-DI 00811877011118
10
510(k) clearances
142
Adverse events
3
Recalls
24
Facilities
Description
A rapid test for the qualitative detection of COVID-19 antigens in nasal swab specimens.
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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Get your free API keyRead the docsData 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.