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

Table. 1.

Table. 1.

List of COVID-19 diagnostic devices using RT-qPCR approved by Ministry of Foods and Drug Safety (MFDS) in Korea

Company Product Approved date
SD BIOSENSOR STANDARDTM M nCoV Real-Time Detection Kit 20.8.31
BioSewoom Inc. Real-Q 2019-nCoV Detection Kit 20.10.6
SEASUN BIOMATERIALS U-TOPTM COVID-19 Detection Kit Plus 20.10.8
CANCERROP Q-Sens COVID-19 Detection Kit 20.10.8
Kogene Biotech PowerChekTM SARS-CoV-2, Influenza A&B Multiplex Real-time PCR Kit 20.11.3
SEASUN BIOMATERIALS AQ-TOPTM COVID-19 Rapid Detection Kit Plus 20.11.23
Kogene Biotech PowerChekTM SARS-CoV-2 Real-time PCR Kit 20.11.26
Seegene Allplex SARS-CoV-2 Assay 20.12.7
CANCERROP Q-Sens COVID-19 Detection Kit V2 20.12.24
BioSewoom Real-Q Direct SARS-CoV2 Detection Kit 21.1.20
Seegene AllplexTM SARS-CoV-2/FluA/FluB/RSV Assay 21.1.26
SML Genetree Ezplex SARS-CoV-2 Kit 21.1.29
invitesBioCore BioCore 2019-nCoV Real Time PCR Kit 21.3.12
LabGenomics LabGunTM COVID-19 ExoFast RT-PCR Kit 21.3.18
OPTOLANE Dr. PCRTM Di20K COVID-19 Detection Kit 21.3.23
SEASUN BIOMATERIALS U-TOPTM SARS-CoV-2 & Flu A/B 21.4.1
OSANG Healthcare GeneFiner COVID-19 Fast RealAmp Kit 21.4.26
BioSewoom Real-Q Direct SARS-CoV2 Detection Kit 21.4.26
BIONEER AccuPower RV1 Real-Time RT-PCR Kit (RV1-1111) 21.4.30
Roche cobas SARS-CoV-2 & Influenza A/B 21.5.4
PaxGenBio PaxView SARS-CoV-2 real-time RT-PCR Kit 21.5.12
BIONEER AccuPower RV1 Multiplex Kit 21.5.26
Genomictree AccuraDTectTM COVID-19 RT-qPCR Kit 21.6.17
SML Genetree Ezplex SARS-CoV2/RV Fast Kit 21.6.21
SMSBIO A+CheQ COVID-19 RT-qPCR Detection Kit 21.6.22
Genematrix NeoPlexTM FluCOVID Kit 21.7.1
SolGent DiaPlexQTM Novel Coronavirus (2019-nCoV) Detection Kit 21.7.22
Genematrix NeoPlexTM COVID-19 Detection 21.8.27
BIONEER AccuPower COVID-19 Multiplex Real-Time RT-PCR Kit (NCVM-1211) 21.9.13
MiCo BioMed Veri-Q COVID-19 Multiplex Detection Kit 21.10.20
KHMedical RADI COVID-19 Detection Kit 21.11.8
iNtRON BIOTECHNOLOGY LiliFTM COVID-19 Multi Real-time RT-PCR Kit 21.12.10
SD BIOSENSOR STANDARDTM M10 SARS-CoV-2 21.12.21
BIOMÉRIEUX BioFire Respiratory Panel 2.1plus (RP2.1plus) 22.2.14
Genes Laboratories GCdiaTM COVID-19 Fast Detection Kit 22.3.14
YD Diagnostics Real Time COVID-19 22.4.4
MiCo BioMed Veri-Q COVID-19 & Flu A/B Multiplex Detection Kit 22.4.13
Abbott Alinity m SARS-CoV-2 AMP Kit 22.4.14
Genes Laboratories GCdiaTM SARS-CoV-2 Detection Kit 22.5.3

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