Product code QMN ยท Class N
Covid-19 Multi-Analyte Antigen Device
0510(k)s in 12 months (0 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in QMN
| Company | 510(k)s | Recalls |
|---|---|---|
| Ortho Clinical Diagnostics Inc | 0 | 2 |
| Becton Dickinson & Co. | 0 | 1 |
| PHASE SCIENTIFIC INTERNATIONAL LIMITED | 0 | 1 |
| Quidel Corporation | 0 | 1 |
| VEO DIAGNOSTICS, LLC | 0 | 1 |
| Versea Diagnostics LLC | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 14, 2024 | Quidel Corporation The Sofia 2 Flu + SARS Antigen FIA employs immunofluorescence technology in a sandwich design that is used with Sofia 2 to detect nucleocapsid protein from influenza A, influenza B, and SARS-CoV-2. Th Open, Classified |
QMN | None listed |
| Jan 17, 2024 | PHASE SCIENTIFIC INTERNATIONAL LIMITED INDICAID COVID-19 Rapid Antigen At-Home Test, REF: P0040 Open, Classified |
QMN | None listed |
| Jun 2, 2023 | Becton Dickinson & Co. BD Veritor System for Rapid Detection of SARS-CoV-2 & Flu A+B, 30 Single Use Test Devices-
Intended for the in vitro, simultaneous qualitative detection and differentiation of SARS-CoV-2 nucleocapsid Open, Classified |
QMN | None listed |
| Jul 27, 2021 | Versea Diagnostics LLC Status COVID-19/Flu Rapid Immunoassay for Direct Detection and Differential Diagnosis of SARS-CoV-2, Influenzas Type A, and Type B Antigens
Simultaneous qualitative detection and differentiation of Terminated |
QMN | None listed |
| Nov 5, 2020 | VEO DIAGNOSTICS, LLC ACCEL ELISA COVID-19 for the detection of total antibodies to SARS-CoV-2
Catalog AE301U
Kit lots: PXCOV073020, PXCOV081220
Expiration dates: January 18, 2021 and January 26, 2021 Terminated |
QMN | None listed |
| Sep 30, 2020 | Ortho Clinical Diagnostics Inc VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Control - Product Usage: For use in monitoring the performance of the VITROS Immunodiagnostic and Integrated Systems when used for the determinatio Terminated |
QMN | None listed |
| Sep 30, 2020 | Ortho Clinical Diagnostics Inc VITROS Immunodiagnostic Products-SARS-CoV-2 IgG Calibrator - Product Usage: In-Vitro Diagnostic (EUA) an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recen Terminated |
QMN | None listed |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.