Home › Device types › QMN
Covid-19 Multi-Analyte Antigen Device
FDA product code QMN · Class N · Unknown
19
Registered devices
3,840
Adverse events
7
Recalls
0
510(k) clearances
Devices with this code
Fluoro-Check TM COVID-19 Antigen Test — NANO-DITECH CORPORATIONCorDx Tyfast — CORETESTS, INC.Nano-Check TM COVID-19 Antigen Test — NANO-DITECH CORPORATIONCorDx Tyfast — CORETESTS, INC.WELLlife™ — WONDFO USA CO., LTD.WELLlife™ — WONDFO USA CO., LTD.WELLlife™ — WONDFO USA CO., LTD.CorDx Tyfast — CORETESTS, INC.CorDx Tyfast — CORETESTS, INC.WELLlife™ — WONDFO USA CO., LTD.WELLlife™ — WONDFO USA CO., LTD.CorDx Tyfast — CORETESTS, INC.WELLlife™ — WONDFO USA CO., LTD.WELLlife™ — WONDFO USA CO., LTD.WELLlife™ — WONDFO USA CO., LTD.Nano-Check TM COVID-19 Antigen Test — NANO-DITECH CORPORATIONWELLlife™ — WONDFO USA CO., LTD.Sofia — QUIDEL CORPORATIONCorDx Tyfast — CORETESTS, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-01-03 | Quidel Corporation | One lot of the Sofia 2 Flu + SARS Antigen FIA (Lot 709083) was labelled with incorrect expiration dates. The kits contain pouched cassettes labeled with an expi |
| 2023-10-25 | PHASE SCIENTIFIC INTERNATIONAL LIMITED | COVID-19 rapid antigen at home tests were released with an incorrect expiration date of 05 April 2024 when the correct expiration should be 21 February 2024. Ex |
| 2023-05-01 | Becton Dickinson & Co. | IFU- Instructions for Use (IFU) package insert and both the IFU packaged with the test kit and the electronic version on the BD website not approved by FDA,spec |
| 2021-07-27 | Versea Diagnostics LLC | Products may have been distributed to customers other than laboratories certified under the Clinical Laboratory Improvement Amendments as stipulated in the Emer |
| 2020-11-05 | VEO DIAGNOSTICS, LLC | Emergency Use Authorization (EUA) removed from list of COVID-19 antibody tests |
| 2020-09-30 | Ortho Clinical Diagnostics Inc | Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased si |
| 2020-09-30 | Ortho Clinical Diagnostics Inc | Elevated sample results signal/cutoff (s/c) values when using eight (8) lots of VITROS immunodiagnostic Products Anti-SARS-CoV-2 IgG Calibrator and decreased si |
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