The Korean Journal of Clinical Laboratory Science : eISSN 2288-1662 / pISSN 1738-3544

Table. 3.

Table. 3.

List of COVID-19 diagnostic devices to detect SARS-CoV-2 antigens approved by Ministry of Foods and Drug Safety in Korea

Company Product Approved date
SD BIOSENSOR STANDARDTM Q COVID-19 Ag Test 20.11.11
GenBody GenBody COVID-19 Ag 20.12.24
SD BIOSENSOR STANDARDTM F COVID-19 Ag FIA 21.1.5
RapiGEN BIOCREDIT COVID-19 Ag 21.3.18
Humasis Humasis COVID-19 Ag Test 21.3.18
Humasis Humasis COVID-19 Home test 21.4.23
SD BIOSENSOR STANDARDTM Q COVID-19 Ag Home Test 21.4.23
Sugentech SGTi-flex COVID-19 Ag 21.5.25
GenBody GenBody FIA COVID-19 Ag 21.6.21
PCL PCL COVID19 Ag Gold 21.6.23
RapiGEN BIOCREDIT COVID-19 Ag Home Test Nasal 21.7.13
Boditech Med ichromaTM COVID-19 Ag 21.7.13
Boditech Med AFIAS COVID-19 Ag 21.7.15
GC녹십자MS GENEDIA W COVID-19 Ag 21.7.29
Precision Biosensor PBCheck COVID-19 Ag 21.8.3
BBB MARK-BTM COVID-19 Ag 21.8.9
Precision Biosensor Exdia COVID-19 Ag 21.8.10
MiCo BioMed VERI-Q COVID-19 Ag Rapid Test 21.8.20
WELLS BIO careUSTM COVID-19 antigen 21.8.25
ASAN PHARM Asan Easy Test COVID-19 Ag 21.9.9
Abott PanbioTM COVID-19 Ag Rapid Test Device (Nasopharyngeal) 21.9.28
wonmed WonMed Covid-19 Ag (WM COVAG-25T) 21.11.10
Z Biotech AnyLab COVID-19 Ag Test Kit 22.1.11
AccessBio CareStart COVID-19 Ag Plus 22.1.11
CALTH AllCheck COVID19 Ag 22.1.13
GenBody GenBody COVID-19 Ag Home Test 22.2.4
Sugentech SGTi-flex COVID-19 Ag Self 22.2.4
SD BIOSENSOR STANDARDTM i-Q COVID-19 Ag Home Test 22.2.11
PCL PCLOK Ⅱ ABC 22.2.15
MEDIAN Diagnostics MDx COVID-19 Ag Home Test 22.2.15
OSANG Healthcare GeneFinderTM COVID-19 Ag Self Test 22.2.15
WELLS BIO careUSTM COVID-19 Antigen Home Test 22.2.17
MEDISENSOR CareUTM COVID-19 SARS-CoV-2 Antigen Rapid Test Kit 22.2.24
GenBody GenBody Influenza/COVID-19 Ag Triple 22.4.11
MEDIAN Diagnostics MDx COVID-19 Ag Rapid Kit 22.4.12
Philosys Gmate® COVID-19 Ag 22.4.12
ImmuneMed IMMUNEMED COVID-19 Ag RAPID 22.4.21
PCL PCL SELF TEST – COVID19 Ag 22.4.29

Reference [25].

Korean J Clin Lab Sci 2022;54:79-94 https://doi.org/10.15324/kjcls.2022.54.2.79
© 2022 Korean J Clin Lab Sci