Product code QKO ยท Class N
Reagent, Coronavirus Serological
0510(k)s in 12 months (0 all time)
0recalls in 12 months (31 all time)
0recalls that name a 510(k)
Top companies in QKO
| Company | 510(k)s | Recalls |
|---|---|---|
| Ortho Clinical Diagnostics | 0 | 5 |
| Beckman Coulter Inc. | 0 | 4 |
| Chembio Diagnostics, Inc | 0 | 3 |
| bioMerieux, Inc. | 0 | 2 |
| Confirm Biosciences Inc | 0 | 2 |
| LumiraDx | 0 | 2 |
| Thera Test Laboratories, Inc. | 0 | 2 |
| Versea Diagnostics LLC | 0 | 2 |
| Ansh Labs, LLC | 0 | 1 |
| AZURE BIOTECH INC | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS SARS-CoV-2 Antibody (IgG/IgM) Test REF 555-10 Open, Classified |
QKO | None listed |
| Apr 18, 2023 | Ortho-Clinical Diagnostics, Inc. VITROS Immunodiagnostic Products Anti-SARSCoV- 2 Total N Antibody
Calibrators programmed onto the Assay Data Disks (ADD) Data Release Versions (DRV):
DRVs 6213 through 6218 supporting VITROS Calibrato Open, Classified |
QKO | None listed |
| Jul 22, 2022 | LumiraDx LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control Terminated |
QKO | None listed |
| Jul 22, 2022 | LumiraDx LumiraDx SARS-CoV-2 Antibody (Ab) Test Strip Terminated |
QKO | None listed |
| May 26, 2022 | Ortho-Clinical Diagnostics, Inc. Anti-SARS-CoV-2 IgG Quantitative Reagent Pack- Intended for use on VITROS
ECi/ECiQ/3600 Immunodiagnostic Systems and VITROS 5600/XT 7600 Integrated Systems.
Product Code: 6199960 Open, Classified |
QKO | None listed |
| Apr 17, 2022 | PROTERIXBIO ProterixBio SARS-CoV-2 (RBD) IgG Antibody Test, and associated ProterixBio Dried Blood Spot Collection Kit, no model number Terminated |
QKO | None listed |
| Jan 13, 2022 | Lusys Laboratories, Inc. COVID-19 IgG/IGM Antibody Test For Detection of COVID-19 IgG and IgM antibodies Catalog No: I-111 Open, Classified |
QKO | None listed |
| Dec 22, 2021 | Empowered Diagnostics LLC ImmunoPass , COVID-19 Neutralizing Antibody Test, NAB 900-60 Completed |
QKO | None listed |
| Sep 22, 2021 | bioMerieux, Inc. VIDAS SARS-COV-2 IgG, Ref 423834-01 Open, Classified |
QKO | None listed |
| Sep 22, 2021 | bioMerieux, Inc. VIDAS SARS-COV-2 IgM, Ref 423833-01 Open, Classified |
QKO | None listed |
| Sep 10, 2021 | Ortho Clinical Diagnostics Inc VITROS Immunodiagnostic Products Anti-SARS-CoV-2 IgG Quantitative Controls (IVD)-
For use in monitoring the performance of the VITROS ECi/ECiQ/3600 Immunodiagnostic Systems and the VITROS 5600/XT 7600 Terminated |
QKO | None listed |
| Aug 5, 2021 | Beckman Coulter Inc. Access SARS CoV-2 IgG (1st IS) Assay:
Access Immunoassay Systems REAGENT PACK, REF C74339
Access SARS-CoV-2 IgG (1st IS) Calibrators, REF C74340
Access SARS-CoV-2 (1st IS) Quality Control (QC), REF Terminated |
QKO | None listed |
| Jul 27, 2021 | Versea Diagnostics LLC Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)
Qualitative detection and differentiation of IgM and IgG antibodies against SARS-CoV-2 in human venous whole blood, plasma (Li+ Terminated |
QKO | None listed |
| Jul 27, 2021 | Versea Diagnostics LLC FaStep COVID-19 IgG/IgM Rapid Test Device
Qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human venous whole blood (sodium EDTA), serum, plasma (sodium EDTA) and Terminated |
QKO | None listed |
| May 7, 2021 | Beckman Coulter Inc. Access SARS-CoV-2 lgG II Calibrator, REF C69058, IVD, CE UDI: (01)15099590742751 Terminated |
QKO | None listed |
| May 7, 2021 | Beckman Coulter Inc. Access SARS CoV-2 lgG II Reagent, REF: C69057, IVD CE UDI: (01)15099590742744 Terminated |
QKO | None listed |
| Apr 26, 2021 | LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD Leccurate SARS-CoV-2, Antibody Rapid Test Kit (Colloidal Gold Immunochromatography), 1 test, IVD. for qualitative detection of IgM and/or IgG antibodies to SARS-CoV-2 in human serum, plasma and veni Completed |
QKO | None listed |
| Mar 2, 2021 | AZURE BIOTECH INC Assure COVID-19 IgG/IgM Rapid Test Device
that include:
1) Pouch Label - FaStep Rapid Diagnostic Test *** Rapid Reliable Simple *** COVID-19 IgG/IgM Rapid Test Device (Whole blood/Serum/Plasma) *** Terminated |
QKO | None listed |
| Jan 29, 2021 | Confirm Biosciences Inc Orient Gene COVID- 19 IgG/ IgM Rapid Test Cassette (Whole
Blood/Serum/Plasma) REF GCCOV-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation o Terminated |
QKO | None listed |
| Jan 29, 2021 | Confirm Biosciences Inc Healgen COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) REF GCC)V-402a - Product Usage: is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM Terminated |
QKO | None listed |
| Jan 19, 2021 | Sky Medical Supplies and Equipments LLC AntIbody to SARS-CoV-2 - Product Usage: (Colloidal Gold) for IgG/IgM Diagnostic Kit, RAPID TEST DEVICE, Whole Blood/Serum/Plasma, SKY Medical Supplies and Equipments, LLC. Terminated |
QKO | None listed |
| Dec 30, 2020 | Beckman Coulter Inc. ACCESS SARS-CoV-2 IgG QC SARS-CoV-2 IgG REF C58964 - Product Usage: use on the Access Family of Immunoassay Systems only. Terminated |
QKO | None listed |
| Dec 18, 2020 | Ansh Labs, LLC AnshLabs - SARS-CoV2 IgM ELISA (u-Capture), IVD, REF: AL-1002, kit contents, Ab PLATE 1 X ! Plate, IgM Sample DIL 1 x 100 mL, ENZ CONJ CONC 1 x 1.5 mL, Calibrators A-C 3 x 1.2 mL, CONJ DIL 1 X 12 mL, Terminated |
QKO | None listed |
| Oct 5, 2020 | Thera Test Laboratories, Inc. EL-Anti-SARS-CoV-2 IgG Kit, Catalog #104-130. Submitted as EUA202128 Terminated |
QKO | None listed |
| Oct 1, 2020 | Epitope Diagnostics, Inc. EDI Novel Coronavirus COVID-19 IgG ELISA Kit, REF: KT-1032
Per label: This kit is intended for qualitative detection of human anti-COVID-19 IgG antibody in human serum. This kit is to be used as an Open, Classified |
QKO | None listed |
| Jul 30, 2020 | Thera Test Laboratories, Inc. EL-Anti-SARS-CoV-2 IgM Kit, Catalog #104-129, IVD. Submitted as EUA202129 Terminated |
QKO | None listed |
| Jul 17, 2020 | Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 IgG Reagent Pack, COV2IgG, VITROS CoV2G. Catalog number 6199919, UDI 10758750033355 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emerge Terminated |
QKO | None listed |
| Jul 17, 2020 | Ortho Clinical Diagnostics VITROS Anti-SARS-CoV-2 Total Reagent, COV2TOT, VITROS CoV2T. Catalog number 6199922, UDI 10758750033386 - Product Usage: Rx ONLY. For in vitro diagnostic and Laboratory Professional use. For emergency Terminated |
QKO | None listed |
| Jun 18, 2020 | Chembio Diagnostics, Inc Chembio DPP Micro Reader II for use with the DPP COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobuli Terminated |
QKO | None listed |
| Jun 18, 2020 | Chembio Diagnostics, Inc Chembio DPP Micro Reader for use with the DPP COVID-19 IgM/IgG System- Rapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G Terminated |
QKO | None listed |
| Jun 18, 2020 | Chembio Diagnostics, Inc Chembio DPP COVID-19 IgM/IgG System- Rrapid immunochromatographic test for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 i Terminated |
QKO | None listed |
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