Medical Supplies

List of COVID-19 In Vitro Diagnostics Device

※ This list is effective as of 15th June 2020
※ Excluding companies that do not agree to disclose information.
※ Click on the manufacturer's name to link to the manufacturer's home page.
If you have any trouble contacting the manufacturer or need any help, please contact us:
Ms. Minjung Kang(mjkang@sba.seoul.kr) , Assistant Manager / Global Marketing Team, Seoul Business Agency(SBA)
Ms. SoonByul Yun(ybhksh@sba.seoul.kr) , Assistant Manager / Global Marketing Team, Seoul Business Agency(SBA)
List of COVID-19 In Vitro Diagnostics Device
No. Item Manufacturer Conctact Number Product Name (Model Name) Remarks
1 Specimen Collection Kit AccuGene +82-32-710-3615 AccuViral Collection Kit (ACN M61.01) Notification
2 Specimen Collection Kit Gene Solution +82-32-582-1282 GENE UTM(Universal Transport Medium) Notification
3 Specimen Collection Kit Noble Biosciences Inc. +82-31-291-0044 UTNFS-3B-1, UTNFS-3B-2, UTNFS-15C, UTNFS-16C Certification
4 Specimen Collection Kit NCORE CO.,LTD. +82-2-866-3514 CORE-MEDIUM, CORE-SWAB Notification
5 Nucleic Acid Extrator Ahram Biosystems, Inc. +82-2-469-3760 PalmTron ™ E1 Portable Nucleic Extractor Notification
Nucleic Acid Extraction kit Palm PCR Viral RNA Direct Extraction Kit
6 Nucleic Acid Extrator Apintech Inc. +82-2-464-0929 MX-16, MX-32, MX-8L Notification
7 Nucleic Acid Extrator Boditech Med Inc. +82-33-243-1400(2) NuActor Notification
Diagnostic Reagents AFIAS COVID-19 Ab Approval for exports only  (Antigen·Antibody)
8 Nucleic Acid Extrator Bioneer Corporation +82-42-930-8657 ExiPrep16 Dx, ExiPrep48 Dx, ExiPrep96 Lite Notification
Nucleic Acid Extraction kit Exiprep® 16 DX viral DNA/RNA Extraction Kit, Exiprep® 48 DX viral DNA/RNA Extraction Kit, Exiprep® 96 DX viral DNA/RNA Extraction Kit
Diagnostic Reagents AccuPower® COVID-19 Real-Time RT-PCR Kit, AccuPower® SARS-CoV-2 Real-Time RT-PCR Kit Approval for exports only (PCR)
PCR Machine ExiCyclerTM96 Certification(Laboratory molecular diagnostic tool)
9 Nucleic Acid Extrator GeneAll Biotechnology Co., Ltd. +82-2-407-0096 (Ext. 400)  GENTI™ 32 Notification
Nucleic Acid Extration kit Ribospin vRD (302-150) / Ribospin vRD II(322-150) 
10 Nucleic Acid Extrator Genolution Inc. +82-2-449-8670 Nextractor® NX-48S Notification
Nucleic Acid Extraction kit Nextractor Viral NA Kit (VN 142/152/162 &VN 143/153/163)
11 Nucleic Acid Extrator Hanwool TPC Co., LTD. +82-70-5014-6264 NC-15 PLUS   Notification
Nucleic Acid Extraction kit AlphaPrepTMViral DNA/RNA Extraction Kit (VDR-B096V)
12 Nucleic Acid Extrator iNtRON Biotechnology, Inc. +82-31-739-5375 Miracle-AutoXT Automated Nucleic Acid Extraction System Notification
Nucleic Acid Extraction kit AutoXT PGS Extraction kit
Diagnostic Reagents LiliF™ COVID-19 Real-time RT-PCR kit Approval for exports only (PCR)
13 Nucleic Acid Extrator KM MEDICAL +82-31-5180-3018 RADI PREP PLUS, KM001 Notification
Nucleic Acid Extraction kit RADI PREP Swab and Stool DNA/RNA KIT, MP002
Diagnostic Reagents RADI COVID-19 detection kit Approval for exports only (PCR)
14 Nucleic Acid Extrator Osang Healthcare Co., Ltd. +82-31-460-9921 +82-31-460-9914 GeneFinder EX-MATE 32 Notification
Diagnostic Reagents GeneFinder COVID-19 Plus RealAmp kit US EUA, Approval for exports only (PCR)
15 ucleic Acid Extrator Sanigen Co., Ltd. +82-1833-8010 Genelix TM Viral DNA-RNAExtraction Kit Notification
Diagnostic Reagents Genelix TM COVID-19 Real-Time PCRKit Approval for exports only(PCR)
16 Diagnostic Reagents BIOCORE CO., LTD. +82-2-2027-6230 BioCore 2019-nCov Real Time PCR Kit US EUA, EUA(PCR), Approval for exports only(PCR)
17 Diagnostic Reagents BioSewoom Inc. +82-2-498-2340 Real-Q 2019-nCoV Detection Kit EUA(PCR), Approval for exports only(PCR)
18 Diagnostic Reagents Kogenebiotech Co. Ltd. +82-2-2026-2150 (Ext. 117) PowerCheckTM2019-nCoVRTPCRkit EUA(PCR), Approval for exports only(PCR)
19 Diagnostic Reagents SD Biosensor Inc. +82-31-300-0438 STANDARD ™ M nCoV Real-Time Detection kit, STANDARD ™ Q COVID-19 IgM/IgG Duo Test, STANDARD ™ Q COVID-19 Ag Test, STANDARD ™ F COVID-19 Ag FIA US EUA, EUA(PCR), Approval for exports only(PCR, Antigen, Antibody)
20 Diagnostic Reagents Seegene Inc.  +82-2240-4000 Allplex™ 2019-nCoV Assay US EUA, EUA(PCR), Approval for exports only(PCR)
21 Diagnostic Reagents SolGent Co., Ltd. +82-2-6001-2956 DiaPlexTMNovelCoronavirus(2019-nCOV)DetectionKit EUA(PCR), Approval for exports only(PCR)
22 Diagnostic Reagents WELLS BIO, Inc +82-3660-6900 careGENE™ COVID-19 RT-PCR kit, careGENE™ N-CoV RT-PCR kit, careUS™ COVID-19 IgM/IgG EUA(PCR), Approval for exports only(PCR, Antibody)
23 Diagnostic Reagents 1drop Inc. +82-31-747-0109 1copy™ COVID-19 qPCR Multi Kit Approval for exports only(PCR)
24 Diagnostic Reagents ASAN Pharmco.,Ltd. +82-31-376-5990 Asan Easy Test COVID-19 IgG/IgM Approval for exports only(Antibody)
25 Diagnostic Reagents B-bio Co., Ltd. +82-70-4163-6891 ChekRTM COVID-19 IgM/IgG Rapid test Approval for exports only(Antibody)
26 Diagnostic Reagents BioMetrix Technology, Inc. +82-33-258-6097 COVID19+9G test™ Approval for exports only(PCR)
27 Diagnostic Reagents CancerROP +82-2-890-8700 Q-Sens 2019-nCoV detection Kit Approval for exports only(PCR)
28 Diagnostic Reagents Dowgene +82-2-6116-6400 Dow QuickFinder 2019-nCoV Real Time PCR Kit Approval for exports only(PCR)
29 Diagnostic Reagents Eudipia Co., Ltd. +82-70-8890-2101 EuDx™ COVID-19 Detection Kit Approval for exports only(PCR)
30 Diagnostic Reagents GENBODY INC. +82-41-523-8990 GeneBody COVID-19 IgG/IgM Approval for exports only(Antibody)
31 Diagnostic Reagents Gencurix +82-2621-7038 GenePro COVID-19 Detection Test Approval for exports only(PCR)
32 Diagnostic Reagents Genematrix +82-31-628-2000 NeoPlex COVID-19 Detection Kit Approval for exports only(PCR)
33 Diagnostic Reagents Genomictree +82-42-861-4551 AccuraDTect SARS-CoV-2 RT-qPCR Kit Approval for exports only(PCR)
34 Diagnostic Reagents GOODGENE INC. +82-2-2088-0055 GG COVID-19 Quadplex Reverse Transcription Real Time Polymerase Chain Reaction Kit Approval for exports only(PCR)
35 Diagnostic Reagents Humasis +82-31-478-8591 Humasis COVID-19 IgG/IgM Test Approval for exports only(Antibody)
36 Diagnostic Reagents Humedix +82-70-7492-5600 Accurate Rapid COVID-19 IgN/IgG Combo Test Approval for exports only(Antibody)
37 Diagnostic Reagents iONEBIO Inc. +82-31-360-1210 iLAMP Novel-CoV19 Detection Kit(iLAMP-CoV19) Approval for exports only(PCR)
38 Diagnostic Reagents Joonghun Pharmaceutical Co., Ltd +82-2-2138-8114 JD COVID-19 qRT-PCR Kit Approval for exports only(PCR)
39 Diagnostic Reagents LabGenomics Co., Ltd. +82-31-628-0726 LabGun™ COVID-19 assay US EUA, Approval for exports only(PCR)
40 Diagnostic Reagents Macrogen +82-2-2180-7221 Axen COVID-19 RT Approval for exports only(PCR)
41 Diagnostic Reagents M Monitor Inc. +82-70-4618-6200 lsopolloCOVID-19 detection kit(premix), lsopolloCOVID-19 detection kit(real-time) Approval for exports only (RT-LAMP)
42 Diagnostic Reagents NanoEntek, INC +82-2-6200-7940 FREND COVID-IgG/IgM Duo Approval for exports only(Antibody)
43 Diagnostic Reagents OPTOLANE Technologies Inc. +82-31-737-7806 Kaira 2019-nCoV Detection Kit Approval for exports only(PCR)
44 Diagnostic Reagents PaxGenBio +82-31-244-5036 PaxView COVID-19 real-time RT-PCR Kit Approval for exports only(PCR)
45 Diagnostic Reagents PCL Inc. +82-2-2144-3951 PCLMD nCoV one step RT-PCR Kit PCL COVID19 Ag Rapid FIA PCL COVID19 IgG/IgM Rapid Gold Approval for exports only(PCR, Antigen·Antibody)
46 Diagnostic Reagents PHILOSYS Co., Ltd. +82-2-553-1421 Gmate COVID-19 Approval for exports only(Antigen)
47 Diagnostic Reagents Prime4dia CO., LTD +82-31-478-3106 P4DETECT COVID-19 IgM/IgG Approval for exports only(Antibody)
48 Diagnostic Reagents Rapigen inc. +82-31-427-4677 BIOCREDIT COVID-19 IgG+IgM Duo, BIOCREDIT COVID-19 Ag Approval for exports only(Antigen, Antibody)
49 Diagnostic Reagents SEASUN BIOMATERIALS +82-2-749-7789 U-TOP™ COVID-19 Detection kit Approval for exports only(PCR)
50 Diagnostic Reagents SML Genetree +82-2-2057-7900 Ezplex 2019-nCoV Real-time PCR Kit Approval for exports only(PCR)
51 Diagnostic Reagents Sugentech, Inc. +82-43-710-2822 SGTi-flex COVID-19 IgM/IgG Approval for exports only(Antibody)
52 Diagnostic Reagents TCM Biosciences Inc. +82-31-698-3041 TCM-Q Corona Ⅲ kit Approval for exports only(PCR)
53 Diagnostic Reagents YD Diagnostics CORP +82-31-329-2011 Molecu Tech Real-Time COVID-19 Approval for exports only(PCR)
54 PCR Machine Genesystem Co., Ltd. +82-42-863-8551~2 GeneChecker UF-300 Certification (On-site molecular diagnostic tool)
55 PCR Machine MiCo BioMed Co., Ltd. +32-70-5227-6021 Veri-Q PCR 316(QD-P100), Veri-Q 316 Coronavirus disease 2019(COVID-19) Detective Kit(nCov-QS) Approval for exports only(On-site molecular diagnostic tool)
56 Walk-Through Booth GREEN PLUS +82-2-6300-2005 Simple movement selection clinic booth(Positive pressure-For doctor) Not a medical device
57 Walk-Through Booth GREEN PURETEC CO., ltd. +82-2-977-8030 Glove-Wall Walking Through System(Negative/Positive pressure-For doctor/patient) Not a medical device
58 Walk-Through Booth KOREA KIYON +82-2-2087-3527 KK-WT-01 (Negative/Positive pressure-For doctor/patient) Not a medical device
59 Walk-Through Booth TSD Global +82-31-638-1225 K-QC 2020 (Negative/Positive pressure-For doctor/patient) Not a medical device
60 Walk-Through Booth Haedam +82-31-225-8833 OEM (Positive pressure-For doctor) Not a medical device
61 Walk-Through Booth Yangji Hospital +82-2-2038-6012 OEM (Negative pressure-For patient) Not a medical device
62 Walk-Through Booth SMG-SNU Boramae Medical Center +82-2-870-3220 OEM (Negative pressure-For patient) Not a medical device
※ ClassⅠ(Notification), ClassⅡ(Certification), ClassⅢ~Ⅳ(Approval)
Source: KHIDI(Korea Health Industry Development Institute)
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