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Medical DevicesKOSDAQ 096530197 approvals

SEEGENE, INC.

Official website

Founded in 2000 and KOSDAQ-listed in 2010, Seegene develops syndromic multiplex PCR molecular diagnostic reagents.

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2000 and listed on KOSDAQ in 2010, Seegene is a molecular diagnostics reagent company built on its Syndromic qPCR technology. It offers reagents such as the Allplex™ Respiratory Panel for respiratory infections, the Allplex™ STI Essential Assay for sexually transmitted infections, and the Allplex™ GI-Bacteria assay for gastrointestinal infections, based on its proprietary DPO™, TOCE™, and MuDT™ technologies and a 3Ct technology that integrates 19 patents. It has obtained approvals for a total of 121 products across countries worldwide, holds patents covering 35 core technologies, and sells through local subsidiaries in nine countries (Italy, UAE, US, Canada, Germany, Brazil, Mexico, Colombia, and South Africa) and distributors in more than 100 countries, with exports accounting for 91% of revenue as of 2024.

Products & technology

  • Allplex™ Respiratory Panel (1A/2/3), Allplex™ RV Master Assay, Allplex™ PneumoBacter AssayDiagnosis of respiratory viral and bacterial infections
  • Allplex™ STI Essential Assay, Allplex™ CT/NG/MG/TV Assay, and othersDiagnosis of sexually transmitted infections including chlamydia, gonorrhea, and trichomoniasis
  • Allplex™ GI-Virus, GI-Bacteria, GI-Parasite, GI-Helminth AssayDiagnosis of gastrointestinal infections such as norovirus and rotavirus
  • Human papillomavirus (HPV) diagnostic productsTesting for high- and low-risk HPV strains associated with cervical cancer

Regulatory approvals

data.go.kr

197 Korean MFDS device approvals · 2008–2026

  • MFDSIVD reagents for extracting nucleic acids2026-02-26
    Product approval · Class 1체외 제신 26-255 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2026-02-25
    Product approval · Class 3체외 제허 26-155 호
  • MFDSIVD reagents for Infectious disease marker(Drug resistant microorganism)2026-02-25
    Product approval · Class 3체외 제허 26-154 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2024-12-23
    Product approval · Class 3체외 제허 24-896 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2024-11-25
    Product approval · Class 3체외 제허 24-830 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2024-06-26
    Product approval · Class 3체외 제허 24-426 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2024-06-19
    Product approval · Class 3체외 제허 24-407 호
  • MFDSIVD reagents for extracting nucleic acids2022-11-28
    Product approval · Class 1체외 제신 22-1675 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2022-05-31
    Product approval · Class 3체외 제허 22-355 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2022-05-31
    Product approval · Class 3체외 제허 22-354 호
  • MFDSIVD reagents for extracting nucleic acids2022-05-30
    Product approval · Class 1체외 제신 22-754 호
  • MFDSIVD reagents for extracting nucleic acids2022-05-30
    Product approval · Class 1체외 제신 22-752 호
Show 68 more
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2022-05-24
    Product approval · Class 3체외 제허 22-333 호
  • MFDSIVD reagents for extracting nucleic acids2022-05-23
    Product approval · Class 1체외 제신 22-725 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2022-05-19
    Product approval · Class 3체외 제허 22-321 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2022-02-28
    Product approval · Class 3체외 제허 22-138 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2021-12-20
    Product approval · Class 3체외 제허 21-1024 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2021-12-13
    Product approval · Class 3체외 제허 21-1000 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2021-11-29
    Product approval · Class 3체외 제허 21-958 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2021-06-30
    Product approval · Class 3체외 제허 21-537 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2021-04-12
    Product approval · Class 3체외 제허 21-284 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2021-04-12
    Product approval · Class 3체외 제허 21-283 호
  • MFDSIVD reagents for extracting nucleic acids2021-04-07
    Product approval · Class 1체외 제신 21-467 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2021-03-04
    Product approval · Class 3체외 제허 21-164 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2021-01-26
    Product approval · Class 3체외 제허 21-65 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2020-12-07
    Product approval · Class 3체외 제허 20-1049 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2020-12-07
    Product approval · Class 3체외 제허 20-1051 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2020-11-30
    Product approval · Class 3체외 제허 20-1005 호
  • MFDSIVD reagents for extracting nucleic acids2020-11-18
    Product approval · Class 1체외 제신 20-1669 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2020-10-19
    Product approval · Class 3체외 제허 20-895 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2020-09-28
    Product approval · Class 3체외 제허 20-845 호
  • MFDSIVD reagents for extracting nucleic acids2020-07-07
    Product approval · Class 1체외 제신 20-1035 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2020-04-28
    Product approval · Class 3체외 제허 20-335 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2020-02-17
    Product approval · Class 3체외 제허 20-119 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2020-02-13
    Product approval · Class 3체외 제허 20-117 호
  • MFDSIVD reagents for Infectious disease marker(Drug resistant microorganism)2019-12-27
    Product approval · Class 3체외 제허 19-842 호
  • MFDSIVD reagents for extracting nucleic acids2019-11-04
    Product approval · Class 1체외 제신 19-1428 호
  • MFDSIVD reagents for extracting nucleic acids2019-10-31
    Product approval · Class 1체외 제신 19-1414 호
  • MFDSIVD reagents for extracting nucleic acids2019-10-31
    Product approval · Class 1체외 제신 19-1415 호
  • MFDSExtractor, nucleic acid2019-10-14
    Product approval · Class 1체외 제신 19-1342 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2019-06-13
    Product approval · Class 3체외 제허 19-367 호
  • MFDSExtractor, nucleic acid2019-05-10
    Product approval · Class 1체외 제신 19-594 호
  • MFDSExtractor, nucleic acid2019-05-09
    Product approval · Class 1체외 제신 19-591 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2019-02-14
    Product approval · Class 3체외 제허 19-97 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2019-02-12
    Product approval · Class 3체외 제허 19-93 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2019-01-22
    Product approval · Class 3체외 제허 19-59 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2019-01-22
    Product approval · Class 3체외 제허 19-58 호
  • MFDSIVD reagents for Infectious disease marker(Drug resistant microorganism)2019-01-22
    Product approval · Class 3체외 제허 19-57 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-12-11
    Product approval · Class 3체외 제허 18-792 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-12-11
    Product approval · Class 3체외 제허 18-791 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-12-11
    Product approval · Class 3체외 제허 18-790 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-12-03
    Product approval · Class 3체외 제허 18-768 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-11-28
    Product approval · Class 3체외 제허 18-759 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-07-24
    Product approval · Class 3체외 제허 18-520 호
  • MFDSIVD reagents for extracting nucleic acids2018-07-16
    Product approval · Class 1체외 제신 18-855 호
  • MFDSIVD reagents for extracting nucleic acids2018-07-16
    Product approval · Class 1체외 제신 18-860 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-06-20
    Product approval · Class 3체외 제허 18-436 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-06-20
    Product approval · Class 3체외 제허 18-435 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-06-20
    Product approval · Class 3체외 제허 18-434 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-06-20
    Product approval · Class 3체외 제허 18-433 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-06-19
    Product approval · Class 3체외 제허 18-426 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-06-19
    Product approval · Class 3체외 제허 18-425 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-06-19
    Product approval · Class 3체외 제허 18-424 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-06-19
    Product approval · Class 3체외 제허 18-423 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-06-19
    Product approval · Class 3체외 제허 18-422 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-06-12
    Product approval · Class 3체외 제허 18-409 호
  • MFDSIVD reagents for extracting nucleic acids2018-06-11
    Product approval · Class 1체외 제신 18-715 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-05-30
    Product approval · Class 3체외 제허 18-384 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-05-16
    Product approval · Class 3체외 제허 18-361 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-05-11
    Product approval · Class 3체외 제허 18-341 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-05-11
    Product approval · Class 3체외 제허 18-340 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-05-04
    Product approval · Class 3체외 제허 18-329 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-05-04
    Product approval · Class 3체외 제허 18-328 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-05-02
    Product approval · Class 3체외 제허 18-320 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-04-19
    Product approval · Class 3체외 제허 18-275 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2018-04-19
    Product approval · Class 3체외 제허 18-274 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2017-05-22
    Product approval · Class 3체외 제허 17-336 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2017-05-10
    Product approval · Class 3체외 제허 17-300 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2017-04-26
    Product approval · Class 3체외 제허 17-290 호
  • MFDSIVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), molecular diagnostics2017-03-31
    Product approval · Class 3체외 제허 17-237 호

Showing the 80 most recent of 197 records.

R&D and key agreements

Source: DART corporate disclosure

신드로믹 정량 PCR(Syndromic qPCR) 및 3Ct 기술 · Holds proprietary DPO™, TOCE™, and MuDT™ technologies and completed 3Ct technology integrating 19 patents to simultaneously test 15 targets and provide quantitative Ct values in a single assay

SGDDS(Seegene Digitalized Development System) · Building an automated reagent development system toward realizing SG OneSystem™

Not yet compiled: business overview. Send us materials and we will add them

Companies approved for the same productsMedical Devices

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

BIONEERCORPORATION9 shared

Bioneer, founded in 1992 and KOSDAQ-listed in 2005, provides gene analysis equipment, molecular diagnostics, and RNAi drug development.

LabGenomics. Co., Ltd.8 shared

KOSDAQ-listed molecular genetic diagnostics company providing NGS-based non-invasive prenatal testing (NIPT) under the MomGuard brand.

Boditech Med Inc.6 shared

KOSDAQ-listed point-of-care immunodiagnostics company supplying diagnostic cartridges and the ichroma/AFIAS instrument series.

GC Medical Science Corporation6 shared

GC Medical Science Corporation, KOSDAQ-listed since 2014, operates diagnostic reagent, blood glucose, and hemodialysis solution businesses.

OSANG HEALTHCARE CO.,LTD.6 shared

Founded 1996, listed on KOSDAQ in 2024, OSANG HEALTHCARE develops and sells biochemistry, immunodiagnostic, and molecular IVD products.

RollingStone Co., Ltd.6 shared

KOSDAQ-listed in-vitro diagnostics company developing the LabChip-based VERI-Q molecular diagnostic device series.

Genesystem Co., Ltd5 shared

Founded 2010, listed on KOSDAQ in 2021, Genesystem develops molecular diagnostic systems, biochips, test kits, and reaction reagents.

HLB PANAGENE Co., LTD.5 shared

Founded in 1976 and KOSDAQ-listed in 2000, HLB PANAGENE develops PNA-based molecular diagnostic and diagnostic automation products.

SD BIOSENSOR INC.5 shared

KOSPI-listed in-vitro diagnostics company known for the STANDARD Q antigen/antibody test kits.

Gencurix Inc.4 shared

Founded 2011, KOSDAQ-listed 2020, Gencurix develops liquid-biopsy diagnostics: breast cancer prognosis and lung/colorectal companion tests.

Genomictree Inc.4 shared

Cancer molecular diagnostics company behind the EarlyTect-C stool-based colorectal cancer test using the SDC2 methylation biomarker.

iNtRON Biotechnology, Inc.4 shared

Founded in 1999 and listed on KOSDAQ in 2011, iNtRON Biotechnology develops bacteriophage-based new drugs via its itLysin and IMPA platforms alongside a molecular diagnostics business.

Sources and updates

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
AI visibility
Measured 2026-08-13

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