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Medical DevicesKOSDAQ 04621082 approvals

HLB PANAGENE Co., LTD.

Official website

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

As of 2026-10-10, HLB PANAGENE Co., LTD. has 82 Korean MFDS device approvals, 1 PubMed-indexed paper on record (counted by the MAA Company Index from its own matching of public databases).

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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

82 Korean MFDS device approvals · 2013–2026

  • MFDSNucleic acid in situ hybridization (FISH, SISH) Ⅰ2026-04-30
    Product approval · Class 1체외 제신 26-552 호
  • MFDSSubsidiary: (주)바이오스퀘어IVD reagents for infectious inflammatory testsRevoked2026-03-16
    Product approval · Class 2체외 제인 26-4242 호
  • MFDSIVD reagents for extracting nucleic acids2025-11-19
    Product approval · Class 1체외 제신 25-1530 호
  • MFDSSubsidiary: (주)바이오스퀘어IVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological methodRevoked2025-10-27
    Product approval · Class 4체외 제허 25-719 호
  • MFDSSubsidiary: (주)바이오스퀘어Capillary blood collection tubeRevoked2025-10-24
    Product approval · Class 1수신 25-2295 호
  • MFDSSubsidiary: (주)바이오스퀘어IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2025-10-17
    Product approval · Class 3체외 제허 25-697 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
  • MFDSSubsidiary: (주)바이오스퀘어IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2024-07-02
    Product approval · Class 3체외 제허 24-438 호
Show 68 more
  • 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
  • MFDSSubsidiary: (주)바이오스퀘어Fluorimetric immunoassay analyzer(FIA), stationaryRevoked2023-12-05
    Product approval · Class 1체외 제신 23-1728 호
  • MFDSSubsidiary: (주)바이오스퀘어IVD reagent for infectious disease, immunological methodRevoked2023-06-19
    Product approval · Class 3체외 제허 23-679 호
  • MFDSSubsidiary: (주)바이오스퀘어IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2023-04-24
    Product approval · Class 3체외 제허 23-529 호
  • MFDSIVD reagents for companion diagnostics with NAT2023-01-19
    Product approval · Class 3체외 제허 23-45 호
  • MFDSSubsidiary: (주)바이오스퀘어IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2023-01-18
    Product approval · Class 3체외 제허 23-43 호
  • MFDSIVD reagents for extracting nucleic acids2022-11-10
    Product approval · Class 1체외 제신 22-1580 호
  • 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
  • MFDSSubsidiary: (주)바이오스퀘어Tool for specimensRevoked2022-08-24
    Product approval · Class 1수신 22-1456 호
  • MFDSSubsidiary: (주)바이오스퀘어IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2022-08-05
    Product approval · Class 3체외 제허 22-529 호
  • MFDSIVD reagents for cancer related gene2022-05-30
    Product approval · Class 3체외 제허 22-349 호
  • MFDSSubsidiary: (주)바이오스퀘어IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2022-05-17
    Product approval · Class 3체외 제허 22-308 호
  • MFDSIVD reagents for extracting nucleic acids2022-04-08
    Product approval · Class 1체외 제신 22-456 호
  • MFDSSubsidiary: (주)바이오스퀘어IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2022-03-21
    Product approval · Class 3체외 제허 22-196 호
  • MFDSSubsidiary: (주)바이오스퀘어Tool for specimensRevoked2022-03-10
    Product approval · Class 1수신 22-399 호
  • MFDSSubsidiary: (주)바이오스퀘어IVD reagents for infectious disease marker(Diagnosis of Sexually transmitted disease, Legally designated infectious pathogens other than ‘high risk pathogens’, Infectious agents with moderate infectivity), immunological methodRevoked2022-03-07
    Product approval · Class 3체외 제허 22-149 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
  • MFDSSubsidiary: (주)바이오스퀘어Fluorimetric immunoassay analyzer(FIA), stationaryRevoked2021-06-17
    Product approval · Class 1체외 제신 21-869 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
  • MFDSSubsidiary: (주)바이오스퀘어Tool for specimensRevoked2020-02-25
    Product approval · Class 1수신 20-466 호
  • MFDSSubsidiary: (주)바이오스퀘어Fluorimetric immunoassay analyzer(FIA), stationaryRevoked2020-01-10
    Product approval · Class 1체외 제신 20-36 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

Showing the 80 most recent of 82 records.

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 58 more patents

AI reads

MAA server logs · IP-verified
101
Times AI engines pulled HLB PANAGENE Co., LTD.'s records

Pulled records become part of each AI's index and keep feeding its answers. When an AI cites from that index, nothing reaches our server — so actual citations are uncounted here and exceed this number.

3
Fetched fresh mid-answer

Times an AI needed something not yet in its index and fetched this page fresh while answering. Citations served from the index leave no trace here.

98
Index crawls

Collected as raw material for future answers.

0
Direct AI-tool queries (MCP)

Queries from users who connected this index to their own AI.

14
live 0
Last 7 days
83
live 3
Last 30 days
101
live 3
All time
  • OpenAIChatGPT-Userlive3
  • OpenAIOAI-SearchBot79
  • GoogleGoogleOther9
  • PerplexityPerplexityBot7
  • AnthropicClaudeBot2
  • MicrosoftBingbot1

Measured since Aug 25, 2026 · 5 AI engines · last read Oct 9, 2026

User-agent strings can be forged, so we do not count them at face value. We count only requests matched against vendor-published IP ranges, or confirmed by forward-verified reverse DNS. MCP queries are actual calls to this index's tool endpoint.

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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.

Boditech Med Inc.11 shared

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

SD BIOSENSOR INC.10 shared

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

OSANG HEALTHCARE CO.,LTD.9 shared

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

Access Bio, Inc.9 shared

Founded in 2002 and KOSDAQ-listed in 2013, Access Bio develops rapid diagnostic tests for malaria, COVID-19, and other infectious diseases.

GC Medical Science Corporation9 shared

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

CALTH. Inc8 shared

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

NanoenTek,Inc.7 shared

Founded in 1987 and listed on KOSDAQ in 2000, NanoenTek develops Lab-On-a-Chip in-vitro diagnostic devices and life science instruments.

HUMASIS CO., LTD.7 shared

KOSDAQ-listed IVD company producing COVID-19 and HIV point-of-care diagnostic reagents alongside rubber products and entertainment businesses.

Precision Biosensor Inc.7 shared

KOSDAQ-listed IVD company producing time-resolved fluorescence immunodiagnostic products under the Exdia TRF brand.

PCL. Inc7 shared

KOSDAQ-listed IVD company using SG Cap™ multiplex diagnostic technology for infectious disease, cancer, and companion animal testing.

Sugentech, Inc.6 shared

Founded in 2011 and KOSDAQ-listed in 2019, Sugentech develops multiplex immunoblot, point-of-care, and digital healthcare diagnostics.

SEEGENE, INC.5 shared

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

Sources and updates

Counts on this page are not company-reported figures. MAA matched records from DART, the Korean MFDS, the US FDA, ClinicalTrials.gov, PubMed and KIPRIS to this company itself, by business registration number or registered name, never by name similarity. They may differ from figures the company publishes.

Company basics
Korea Exchange · DART
Business content
Compiled from disclosure filings
Approvals & clinical trials
Korean MFDS (data.go.kr) · US FDA openFDA — updated weekly
Key disclosures
KRX KIND via OpenDART exchange filings — updated daily
Global clinical trials
ClinicalTrials.gov (US NIH) — sponsor-matched, updated weekly
Financials
DART corporate disclosure filings — annual
Publications
PubMed (US National Library of Medicine) — affiliation-matched, updated daily
Patents
KIPRIS (Korea Institute of Patent Information) — applicant-matched, updated monthly
AI reads
Our server logs, IP-verified every 6 hours
AI visibility
Measured 2026-10-01

This page is compiled from public sources without the company's involvement. If anything is inaccurate or incomplete, please let us know. Materials provided by the company are labelled as such.

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