List of COVID-19 In Vitro Diagnostics Device
※ This list is effective as of 1th September 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)
| 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 | Ensol Biosciences Inc. | +82-42-939-4545 | En™ Collection and Transport System | Notification |
| 3 | Specimen Collection Kit | Gene Solution | +82-32-582-1282 | GENE UTM(Universal Transport Medium) | Notification |
| 4 | Specimen Collection Kit | PHILOSYS Co., Ltd | +82-2-553-1421 | Gmate® UTM(PS-019u) | Notification |
| Diagnostic Reagents | Gmate® COVID-19(PS-019s) | Approval for exports only (Antigen) | |||
| 5 | Specimen Collection Kit | SG Medical Inc. | +82-2-2240-7041 | Gene™ Set | Notification |
| Diagnostic Reagents | R-FIND COVID-19 IgGELISA, R-FIND COVID-19 IgG/M/A ELISA, R-FIND COVID-19 IgM ELISA | Approval for exports only (Antigen) | |||
| 7 | Specimen Collection Kit | Noble Biosciences Inc. | +82-31-291-0044 | UTNFS-3B-1, UTNFS-3B-2, UTNFS-15C, UTNFS-16C | Certification |
| 8 | Specimen Collection Kit | INCORE CO.,LTD. | +82-2-866-3514 | CORE-MEDIUM, CORE-SWAB | Notification |
| 9 | 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 | ||||
| 10 | Nucleic Acid Extrator | Apintech Inc. | +82-2-464-0929 | MX-16, MX-32, MX-8L | Notification |
| 11 | 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) | |||
| 12 | 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) | |||
| 13 | 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) | ||||
| 14 | 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) | ||||
| 15 | 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) | ||||
| 16 | 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) | |||
| 17 | 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) | |||
| 18 | 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) | |||
| 19 | 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) | |||
| 20 | Diagnostic Reagents | SD Biosensor Inc. | +82-31-300-0438 | STANDARD™ M nCoV Real-Time Detection kit, | Notification |
| STANDARD™ Q COVID-19 IgM/IgG Duo Test, STANDARD ™ Q COVID-19 Ag Test, STANDARD ™ F COVID-19 Ag FIA | US EUA, Approval for exports only(PCR, Antigen, Antibody) | ||||
| 21 | Diagnostic Reagents | BioSewoom Inc. | +82-2-498-2340 | Real-Q Direct SARS-CoV-2 Detection Kit | Emergency EUA(PCR) |
| Real-Q 2019-nCoV Detection Kit | EUA(PCR), Approval for exports only(PCR) | ||||
| 22 | Diagnostic Reagents | LabGenomics Ci., Ltd. | +82-31-628-0726 | LabGun™ COVID-19 Fast RT-PCR Kit | Emergency EUA(PCR) |
| LabGun™ COVID-19 assay | US EUA, Approval for exports only(PCR) | ||||
| 23 | Diagnostic Reagents | SML Genetree | +82-2-2057-7900 | Ezplex SARS-CoV-2 Fast Kit | Emergency EUA(PCR) |
| Ezplex 2019-nCov Real-time PCR Kit | Approval for exports only(PCR) | ||||
| 24 | Diagnostic Reagents | BIOCORE CO., LTD. | +82-2-2027-6230 | BioCore 2019-nCov Real Time PCR Kit | EUA(PCR), Approval for exports only(PCR) |
| 25 | Diagnostic Reagents | Kogenebiotech Co. Ltd. | +82-2-2026-2150 (Ext. 117) | PowerCheckTM2019-nCoVRTPCRkit | EUA(PCR), Approval for exports only(PCR) |
| 26 | Diagnostic Reagents | Seegene Inc. | +82-2240-4000 | Allplex™ 2019-nCoV Assay | US EUA, EUA(PCR), Approval for exports only(PCR) |
| 27 | Diagnostic Reagents | SolGent Co., Ltd. | +82-2-6001-2956 | DiaPlexTMNovelCoronavirus(2019-nCOV)DetectionKit | EUA(PCR), Approval for exports only(PCR) |
| 28 | 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) |
| 29 | Diagnostic Reagents | Absology Co., Ltd. | +82-31-348-8690 | Absoludy COVID-19 IgM/IgG Rapid, INIST COVID-19 IgM/IgG Rapid(ABCVR-025) | Approval for exports only(PCR) |
| 30 | Diagnostic Reagents | 1drop Inc. | +82-31-747-0109 | 1copy™ COVID-19 qPCR Multi Kit | Approval for exports only(Antibody) |
| 31 | Diagnostic Reagents | ASAN Pharmco.,Ltd. | +82-31-376-5990 | Asan Easy Test COVID-19 IgG/IgM | Approval for exports only(Antibody) |
| 32 | Diagnostic Reagents | B-bio Co., Ltd. | +82-70-4163-6891 | ChekRTM COVID-19 IgM/IgG Rapid test | Approval for exports only(Antibody) |
| 33 | Diagnostic Reagents | BioMetrix Technology, Inc. | +82-33-258-6097 | COVID19+9G test™ | Approval for exports only(PCR) |
| 34 | Diagnostic Reagents | CancerROP | +82-2-890-8700 | Q-Sens 2019-nCoV detection Kit | Approval for exports only(PCR) |
| 35 | Diagnostic Reagents | Celltrion Healthcare | +82-32-850-6428 | Celltrion DiaTrust™ COVID-19 IgG/IgM Rapid Test | Approval for exports only(Antibody) |
| 36 | Diagnostic Reagents | Dowgene | +82-2-6116-6400 | Dow QuickFinder 2019-nCoV Real Time PCR Kit | Approval for exports only(PCR) |
| 37 | Diagnostic Reagents | Eudipia Co., Ltd. | +82-70-8890-2101 | EuDx™ COVID-19 Detection Kit | Approval for exports only(PCR) |
| 38 | Diagnostic Reagents | Gencurix | +82-2621-7038 | GenePro COVID-19 Detection Test | Approval for exports only(PCR) |
| 39 | Diagnostic Reagents | GENBODY INC. | +82-41-523-8990 | GeneBody COVID-19 IgG/IgM | Approval for exports only(Antibody) |
| 40 | Diagnostic Reagents | Gencurix | +82-2621-7038 | GenePro COVID-19 Detection Test | Approval for exports only(PCR) |
| 41 | Diagnostic Reagents | Genomictree | +82-42-861-4551 | AccuraDTect SARS-CoV-2 RT-qPCR Kit | Approval for exports only(PCR) |
| 42 | 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) |
| 43 | Diagnostic Reagents | Humasis | +82-31-478-8591 | Humasis COVID-19 IgG/IgM Test | Approval for exports only(Antibody) |
| 44 | Diagnostic Reagents | Humedix | +82-70-7492-5600 | Accurate Rapid COVID-19 IgN/IgG Combo Test | Approval for exports only(Antibody) |
| 45 | Diagnostic Reagents | iONEBIO Inc. | +82-31-360-1210 | iLAMP Novel-CoV19 Detection Kit(iLAMP-CoV19) | Approval for exports only(PCR) |
| 46 | Diagnostic Reagents | Joonghun Pharmaceutical Co., Ltd | +82-2-2138-8114 | JD COVID-19 qRT-PCR Kit | Approval for exports only(PCR) |
| 47 | Diagnostic Reagents | Macrogen | +82-2-2180-7221 | Axen COVID-19 RT | Approval for exports only(PCR) |
| 48 | Diagnostic Reagents | Median Diagnostics Inc | +82-2-3401-0110 | MDx® COVID-19 Ab Rapid Test | Approval for exports only(Antibody) |
| 49 | Diagnostic Reagents | MicroDigital Co., Ltd. | +82-31-701-2225 | MDGen AB96-COVID-19 IgG | Approval for exports only(Antibody) |
| 50 | 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) |
| 51 | Diagnostic Reagents | NanoBioLife Inc. | +82-2-858-3635 | Nano-KGIC™ COVID-19 IgM/IgG Kit | Approval for exports only(Antibody) |
| 52 | Diagnostic Reagents | NanoEntek, INC | +82-2-6200-7940 | FREND COVID-IgG/IgM Duo | Approval for exports only(Antibody) |
| 53 | Diagnostic Reagents | OPTOLANE Technologies Inc. | +82-31-737-7806 | Kaira 2019-nCoV Detection Kit, Dr.PCR 20K COVID-19 Detection Kit | Approval for exports only(PCR) |
| 54 | Diagnostic Reagents | PaxGenBio | +82-31-244-5036 | PaxView COVID-19 real-time RT-PCR Kit | Approval for exports only(PCR) |
| 55 | 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) |
| 56 | Diagnostic Reagents | Prime4dia CO., LTD | +82-31-478-3106 | P4DETECT COVID-19 IgM/IgG | Approval for exports only(Antibody) |
| 57 | Diagnostic Reagents | Proteome Tech Inc. | +82-2-6968-5278 | KOVIcheck COVID-19 IgG/IgM | Approval for exports only(Antibody) |
| 58 | Diagnostic Reagents | Rapigen inc. | +82-31-427-4677 | BIOCREDIT COVID-19 IgG+IgM Duo, BIOCREDIT COVID-19 Ag | Approval for exports only(Antigen, Antibody) |
| 59 | Diagnostic Reagents | SEASUN BIOMATERIALS | +82-2-749-7789 | U-TOP™ COVID-19 Detection kit | Approval for exports only(PCR) |
| 60 | Diagnostic Reagents | Sugentech, Inc. | +82-43-710-2822 | SGTi-flex COVID-19 IgM/IgG | Approval for exports only(Antibody) |
| 61 | Diagnostic Reagents | TCM Biosciences Inc. | +82-31-698-3041 | TCM-Q Corona Ⅲ kit | Approval for exports only(PCR) |
| 62 | Diagnostic Reagents | TNS CO., Ltd. | +82-70-7007-9151 | COVID-19 RT-PCR PNA Kit | US EUA, Approval for exports only(PCR) |
| 63 | Diagnostic Reagents | YD Diagnostics CORP | +82-31-329-2011 | Molecu Tech Real-Time COVID-19 | Approval for exports only(PCR) |
| 64 | PCR Machine | Genesystem Co., Ltd. | +82-42-863-8551~2 | GeneChecker UF-300 | Certification (On-site molecular diagnostic tool) |
| Diagnostic Reagents | SARS-CoV-2 | Approval for exports only(PCR) | |||
| 65 | 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) |
| 66 | Walk-Through Booth | GREEN PLUS | +82-2-6300-2005 | Simple movement selection clinic booth(Positive pressure-For doctor) | Not a medical device |
| 67 | 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 |
| 68 | Walk-Through Booth | KOREA KIYON | +82-2-2087-3527 | KK-WT-01 (Negative/Positive pressure-For doctor/patient) | Not a medical device |
| 69 | Walk-Through Booth | Winicare | +82-31-788-9065 | Smart Mobile Infection Clinic (Negative/Positive pressure-For doctor/patient) | Not a medical device |
| 70 | Walk-Through Booth | TSD Global | +82-31-638-1225 | K-QC 2020 (Negative/Positive pressure-For doctor/patient) | Not a medical device |
| 71 | Walk-Through Booth | Haedam | +82-31-225-8833 | OEM (Positive pressure-For doctor) | Not a medical device |
| 72 | Walk-Through Booth | Yangji Hospital | +82-2-2038-6012 | OEM (Negative pressure-For patient) | Not a medical device |
| 73 | Walk-Through Booth | SMG-SNU Boramae Medical Center | +82-2-870-3220 | OEM (Negative pressure-For patient) | Not a medical device |
※ Source: KHIDI(Korea Health Industry Development Institute)
