Panels › Microbiology › Product code QYT · Class 2
Over-The-Counter Covid-19 Antigen Test
Regulation 866.3984
3510(k)s in 12 months (14 all time)
0recalls in 12 months (3 all time)
0recalls that name a 510(k)
Top companies in QYT
| Company | 510(k)s | Recalls |
|---|---|---|
| FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD | 0 | 3 |
| ACON Laboratories, Inc. | 2 | 0 |
| Abbott Diagnostics Scarborough, Inc. | 1 | 0 |
| Access Bio, Inc. | 1 | 0 |
| Assure Tech., LLC | 1 | 0 |
| CorDx, Inc. | 1 | 0 |
| Genabio Diagnostics, Inc. | 1 | 0 |
| Genbody.Inc. | 1 | 0 |
| Guangzhou Wondfo Biotech Co., Ltd. | 1 | 0 |
| Healgen Scientific,, LLC | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2024 | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD DVOT SARS-CoV-2 & RSV &MP &ADV & FIu A/B Antigen Combo Test Kit, Model Number ACT01 Open, Classified |
QYT | None listed |
| Sep 27, 2024 | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD DVOT SARS-Cov-2 &Influenza A+B Antigen Combo Test Kit, Model Number FAT01 Open, Classified |
QYT | None listed |
| Sep 27, 2024 | FENG CHUN YUAN MEDICAL EQUIPMENT (SHENZHEN)CO.,LTD DVOT SARS-CoV-2 ANTIGEN TEST KIT, Model Number FCY-AGT-01 Open, Classified |
QYT | None listed |
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