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Medical DevicesKOSDAQ 04621064 approvals

HLB PANAGENE Co., LTD.

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

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Business overview

Source: DART corporate disclosure

Founded in 1976 and listed on KOSDAQ in 2000, HLB PANAGENE is a biotech venture company developing technologies and products based on PNA (Peptide Nucleic Acid), an artificial gene. Building on its PNA materials business, it supplies molecular diagnostic products under the PNAClamp™, PANAMutyper™, OncoTector™, PANA RealTyper™, and PANA qPCR™ brands along with PANAMAX nucleic acid extraction equipment and reagents, while its subsidiary Biosquare Co., Ltd. operates an immunodiagnostic platform business based on Quantum Pack technology. PNAClamp™ detects somatic mutations including EGFR, KRAS, NRAS, and BRAF for companion diagnostics of cancer targeted therapies, and PANA RealTyper™ provides HPV 32-genotype testing as well as 22-genotype plus 18-screening testing, with products sold domestically and internationally.

Regulatory approvals

data.go.kr

64 Korean MFDS device approvals · 2013–2026

  • MFDSNucleic acid in situ hybridization (FISH, SISH) Ⅰ2026-04-30
    Product approval · Class 1체외 제신 26-552 호
  • MFDSIVD reagents for extracting nucleic acids2025-11-19
    Product approval · Class 1체외 제신 25-1530 호
  • MFDSExtractor, nucleic acid2025-07-25
    Product approval · Class 1체외 수신 25-1607 호
  • MFDSIVD reagents for extracting nucleic acids2025-06-12
    Product approval · Class 1체외 수신 25-1211 호
  • MFDSIVD reagents for extracting nucleic acids2025-05-26
    Product approval · Class 1체외 수신 25-1064 호
  • MFDSIVD reagents for companion diagnostics with NAT2025-02-04
    Product approval · Class 3체외 제허 25-64 호
  • MFDSIVD reagents for extracting nucleic acids2024-08-19
    Product approval · Class 1체외 제신 24-1052 호
  • MFDSIVD reagents for extracting nucleic acids2024-03-06
    Product approval · Class 1체외 제신 24-281 호
  • MFDSIVD reagents for cancer related gene2023-12-21
    Product approval · Class 3체외 제허 23-1168 호
  • MFDSIVD reagents for cancer related gene2023-12-21
    Product approval · Class 3체외 제허 23-1167 호
  • MFDSIVD reagents for companion diagnostics with NAT2023-01-19
    Product approval · Class 3체외 제허 23-45 호
  • MFDSIVD reagents for extracting nucleic acids2022-11-10
    Product approval · Class 1체외 제신 22-1580 호
Show 52 more
  • MFDSIVD reagents for cancer related gene2022-09-28
    Product approval · Class 3체외 제허 22-649 호
  • MFDSIVD reagents for extracting nucleic acids2022-09-20
    Product approval · Class 1체외 제신 22-1305 호
  • MFDSIVD reagents for cancer related gene2022-05-30
    Product approval · Class 3체외 제허 22-349 호
  • MFDSIVD reagents for extracting nucleic acids2022-04-08
    Product approval · Class 1체외 제신 22-456 호
  • MFDSIVD reagents for companion diagnostics with NAT2022-02-17
    Product approval · Class 3체외 제허 22-112 호
  • MFDSIVD reagents for cancer related gene2021-11-17
    Product approval · Class 3체외 제허 21-919 호
  • MFDSIVD reagents for extracting nucleic acids2021-09-27
    Product approval · Class 1체외 제신 21-1287 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 diagnostics2021-05-04
    Product approval · Class 3체외 제허 21-345 호
  • MFDSIVD reagents for extracting nucleic acids2021-04-30
    Product approval · Class 1체외 제신 21-588 호
  • MFDSIVD reagents for extracting nucleic acids2021-04-30
    Product approval · Class 1체외 제신 21-587 호
  • MFDSExtractor, nucleic acid2020-12-30
    Product approval · Class 1체외 제신 20-1959 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 diagnostics2019-10-29
    Product approval · Class 3체외 제허 19-695 호
  • MFDSExtractor, nucleic acid2019-07-11
    Product approval · Class 1체외 제신 19-945 호
  • MFDSIVD reagents for extracting nucleic acids2019-07-03
    Product approval · Class 1체외 제신 19-885 호
  • MFDSIVD reagents for extracting nucleic acids2019-07-03
    Product approval · Class 1체외 제신 19-887 호
  • MFDSIVD reagents for extracting nucleic acids2019-07-03
    Product approval · Class 1체외 제신 19-888 호
  • MFDSIVD reagents for Infectious disease marker(Drug resistant microorganism)2019-03-21
    Product approval · Class 3체외 제허 19-171 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 diagnostics2018-10-24
    Product approval · Class 3체외 제허 18-704 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 diagnosticsRevoked2018-09-10
    Product approval · Class 3체외 제허 18-622 호
  • MFDSIVD reagents for cancer related gene2018-05-31
    Product approval · Class 3체외 제허 18-390 호
  • MFDSIVD reagents for cancer related geneRevoked2018-04-24
    Product approval · Class 3체외 제허 18-301 호
  • MFDSIVD reagents for cancer related gene2018-04-06
    Product approval · Class 3체외 제허 18-230 호
  • MFDSIVD reagents for Infectious disease marker(Drug resistant microorganism)Revoked2017-12-08
    Product approval · Class 3체외 제허 17-924 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 diagnostics2017-07-03
    Product approval · Class 3체외 제허 17-456 호
  • MFDSIVD reagents for companion diagnostics with NAT2017-02-24
    Product approval · Class 3체외 제허 17-145 호
  • MFDSIVD reagents for cancer related gene2017-01-31
    Product approval · Class 3체외 제허 17-85 호
  • MFDSIVD reagents for cancer related gene2017-01-31
    Product approval · Class 3체외 제허 17-84 호
  • MFDSIVD reagents for cancer related gene2016-10-14
    Product approval · Class 3체외 제허 16-754 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 diagnostics2016-09-21
    Product approval · Class 3체외 제허 16-705 호
  • MFDSIVD reagents for cancer related gene2016-09-08
    Product approval · Class 3체외 제허 16-683 호
  • MFDSIVD reagents for cancer related gene2016-08-01
    Product approval · Class 3체외 제허 16-568 호
  • MFDSIVD reagents for cancer related gene2016-08-01
    Product approval · Class 3체외 제허 16-567 호
  • MFDSIVD reagents for cancer related gene2016-08-01
    Product approval · Class 3체외 제허 16-566 호
  • MFDSIVD reagents for cancer related gene2016-05-24
    Product approval · Class 3체외 제허 16-381 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 diagnosticsRevoked2015-07-01
    Product approval · Class 3체외 제허 15-1065 호
  • MFDSIVD reagents for cancer related geneRevoked2015-07-01
    Product approval · Class 3체외 제허 15-1066 호
  • MFDSIVD reagents for cancer related gene2015-03-17
    Product approval · Class 3체외 제허 15-371 호
  • MFDSIVD reagents for cancer related geneRevoked2015-03-06
    Product approval · Class 3체외 제허 15-319 호
  • MFDSIVD reagents for cancer related geneRevoked2014-11-26
    Product approval · Class 3체외 제허 14-2524 호
  • MFDSIVD reagents for cancer related geneRevoked2014-11-26
    Product approval · Class 3체외 제허 14-2525 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 diagnosticsRevoked2014-11-10
    Product approval · Class 3체외 제허 14-1964 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 diagnosticsRevoked2014-11-10
    Product approval · Class 3체외 제허 14-1968 호
  • MFDSIVD reagents for cancer related gene2014-11-03
    Product approval · Class 3체외 제허 14-1926 호
  • MFDSIVD reagents for cancer related geneRevoked2014-07-01
    Product approval · Class 3체외 제허 14-1239 호
  • MFDSIVD reagents for cancer related gene2013-10-04
    Product approval · Class 3체외 제허 13-1677 호
  • MFDSIVD reagents for cancer related gene2013-09-17
    Product approval · Class 3체외 제허 13-1626 호
  • MFDSIVD reagents for cancer related geneRevoked2013-09-17
    Product approval · Class 3체외 제허 13-1627 호
  • MFDSIVD reagents for cancer related gene2013-06-20
    Product approval · Class 3체외 제허 13-1070 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 diagnostics2013-03-29
    Product approval · Class 3체외 제허 13-612 호
  • MFDSIVD reagents for cancer related gene2013-01-02
    Product approval · Class 3체외 제허 13-27 호
  • MFDSIVD reagents for cancer related geneRevoked2013-01-02
    Product approval · Class 3체외 제허 13-28 호
  • MFDSIVD reagents for cancer related geneRevoked2013-01-02
    Product approval · Class 3체외 제허 13-29 호

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Companies approved for the same productsMedical Devices

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

SEEGENE, INC.5 shared

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

BIONEERCORPORATION4 shared

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

Boditech Med Inc.4 shared

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

Gencurix Inc.4 shared

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

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.

CALTH. Inc3 shared

Holds manufacturing approvals for 42 point-of-care diagnostic reagents and devices in the IVD market.

GC Medical Science Corporation3 shared

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

Genesystem Co., Ltd3 shared

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

Genomictree Inc.3 shared

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

LabGenomics. Co., Ltd.3 shared

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

RollingStone Co., Ltd.3 shared

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

SD BIOSENSOR INC.3 shared

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

Sources and updates

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

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