Home › Device types › QKO
Reagent, Coronavirus Serological
FDA product code QKO · Class N · Unknown
82
Registered devices
1,550
Adverse events
31
Recalls
0
510(k) clearances
Devices with this code
VITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Anti-SARS-CoV-2 ELISA (IgA) — EUROIMMUN Medizinische Labordiagnostika AGAlinity — Abbott Ireland DiagnosticsFastep COVID-19 IgG/IgM Rapid Test Device — ASSURE TECH. (HANGZHOU) CO., LTD.Access SARS-CoV-2 IgM — Beckman Coulter, Inc.Nano-CheckTM COVID-19 IgG/IgM Antibody Test — NANO-DITECH CORPORATIONAlinity — Abbott Ireland DiagnosticsAlinity — ABBOTT LABORATORIESVITROS — ORTHO-CLINICAL DIAGNOSTICS, INC.Lyher — Hangzhou Laihe Biotech Co.,Ltd.VITROS — ORTHO CLINICAL DIAGNOSTICSARCHITECT — Abbott Ireland DiagnosticsDV/DM COV2T/CV2T POS/NEG CTRL — Siemens Healthcare Diagnostics Inc.ARCHITECT — Abbott Ireland DiagnosticsSARS-CoV-2 IgG AccuBind ELISA Test System - 192 Wells — MONOBIND, INC.Alinity — Abbott Ireland DiagnosticsACON SARS-CoV-2 IgG/IgM Rapid Test — Acon Laboratories, Inc.Alinity — Abbott Ireland DiagnosticsSCoV-2 Detect™ IgM ELISA — INBIOS INTERNATIONAL, INCIDS SARS-COV-2 IgG — IMMUNODIAGNOSTIC SYSTEMS LIMITEDVITROS — ORTHO CLINICAL DIAGNOSTICSARCHITECT — Abbott Ireland DiagnosticsVITROS — ORTHO CLINICAL DIAGNOSTICSAccess SARS-CoV-2 IgG — Beckman Coulter, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2023-05-22 | Universal Meditech Inc. | Universal Meditech Inc. was violatively distributing PrestiBio" Breastmilk Alcohol Test Strip, DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test, HealthyWiser KetoFa |
| 2023-03-09 | Ortho-Clinical Diagnostics, Inc. | Incorrect Number of Calibrator Levels (2) Set for the VITROS Immunodiagnostics Products Anti-SARS-CoV-2 Total N Antibody Calibrators in Assay Data Disks (ADD), |
| 2022-06-24 | LumiraDx | Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA. |
| 2022-06-24 | LumiraDx | Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA. |
| 2022-05-26 | Ortho-Clinical Diagnostics, Inc. | On-Analyzer Stability (OAS) time, supported for 6 weeks; not 8 weeks as is currently stated in the Instructions For Use (IFU). |
| 2022-04-17 | PROTERIXBIO | FDA review concluded that the test is insufficiently supported by clinical performance data, and results reported may not have been accurate (false positives or |
| 2022-01-13 | Lusys Laboratories, Inc. | COVID-19 test kits (Antibody Rapid Test kit and Antigen Rapid Test Kit) are not authorized, cleared, or approved for marketing and/or distribution in the U.S. |
| 2021-12-22 | Empowered Diagnostics LLC | COVID test kits were offered for sale and distributed to consumers in the United States without marketing approval, clearance, or authorization from FDA. |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
| 2021-09-22 | bioMerieux, Inc. | bioMerieux has been receiving an increasing number of complaints linked to a VIDAS substrate error. It prevents the test from being run, therefore leads to pote |
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