List of COVID-19 diagnostic devices to detect SARS-CoV-2 antibodies approved by Ministry of Foods and Drug Safety in Korea
| Company | Product | Approved date |
|---|---|---|
| SD BIOSENSOR | STANDARDTM Q COVID-19 IgM/IgG Plus Test | 20.11.6 |
| Sugentech | SGTi-flex COVID-19 IgM/IgG | 20.12.18 |
| SD BIOSENSOR | STANDARDTM F COVID-19 IgM/IgG Combo FIA | 21.1.26 |
| Roche | Elecsys Anti-SARS-CoV-2 | 21.4.16 |
| Simens Healthineers | ADVIA Centaur SARS-CoV-2 Total (COV2T) | 21.4.16 |
| GenBody | GenBody COVID-19 IgM/IgG | 21.4.20 |
| Humasis | Humasis COVID-19 IgG/IgM Test | 21.5.6 |
| SG Medical | R-FIND COVID-19 IgM ELISA | 21.5.6 |
| SG Medical | R-FIND COVID-19 IgG ELISA | 21.5.6 |
| SG Medical | R-FIND COVID-19 IgG/M/A ELISA | 21.5.6 |
| WELLS BIO | careUSTM COVID-19 IgM/IgG Ab | 21.5.27 |
| LG Chem | AdvanSureTM SARS-CoV-2 IgG (S1) ELISA | 21.5.27 |
| PCL | PCL SARS-CoV-2 IgG EIA | 21.8.12 |
| MiCo BioMed | COVID-19 Biokit IgG/IgM | 21.8.13 |
| Abott | SARS-CoV-2 IgG Ⅱ Quant Reagent Kit | 21.12.10 |
| NanoEnTek | FREND COVID-19 SP | 22.1.24 |
| PCL | PCLOCK Ⅱ SARS-CoV-2 Dual IgG | 22.2.15 |
| Simens Healthineers | ADVIA Centaur SARS-CoV-2 IgG (sCOVG) | 22.3.11 |
| ASAN PHARM | Asan Easy Test COVID-19 IgG/IgM (N) | 22.3.14 |
| LG Chem | AdvanSureTM SARS-CoV-2 IgG (RBD) ELISA | 22.3.17 |
| AccessBio | CareStartTM COVID-19 IgM/IgG Ab | 22.4.18 |
Reference [25].
