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Medical DevicesKOSDAQ 24182061 approvals

PCL. Inc

Official website

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

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Business overview

Source: DART corporate disclosure

Founded in 2008 and listed on KOSDAQ in 2017, PCL is an in-vitro diagnostics company. Based on its SG Cap™ multiplex diagnostic technology, it manufactures and sells diagnostic kits and analyzers for infectious diseases (HIV/HBV/HCV), cancers (pancreatic, colorectal, liver, prostate, ovarian), COVID-19, influenza (flu/RSV), and autoimmune disease, as well as diagnostic kits for companion animals (dogs and cats). Since 2024 it has begun supplying medications for chronic disease management and has expanded into antibacterial additive film materials and cosmetics based on its transparent polymer material technology.

Products & technology

  • SG Cap™ multiplex diagnostic platformhigh-risk infectious disease (HIV/HBV/HCV) diagnostics
  • cancer diagnostic kitspancreatic, colorectal, liver, prostate, ovarian cancer diagnostics
  • COVID-19/influenza diagnostic kitsCOVID-19, influenza, RSV diagnostics
  • companion animal diagnostic kitscanine and feline disease diagnostics

Regulatory approvals

data.go.kr

61 Korean MFDS device approvals · 2014–2026

  • MFDSIVD reagents for inflammatory tests2026-04-16
    Product approval · Class 2체외 제인 26-4336 호
  • MFDSFlow cytometry2026-03-11
    Product approval · Class 1체외 제신 26-304 호
  • MFDSEndoscopic dilator, cavity2025-07-08
    Product approval · Class 1제신 25-869 호
  • MFDSIVD reagents for fecal occult blood test2024-12-20
    Product approval · Class 2체외 제인 24-1173 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 diagnostics2024-12-06
    Product approval · Class 3체외 제허 24-861 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 diagnostics2024-08-13
    Product approval · Class 3체외 제허 24-544 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 diagnostics2024-08-13
    Product approval · Class 3체외 제허 24-543 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), immunological method2024-06-21
    Product approval · Class 3체외 제허 24-416 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 diagnostics2024-06-10
    Product approval · Class 3체외 제허 24-390 호
  • MFDSIVD reagents for diabetes mellitus2023-12-27
    Product approval · Class 2체외 수인 23-4937 호
  • MFDSIVD reagents for diabetes mellitus2023-12-22
    Product approval · Class 2체외 수인 23-4928 호
  • MFDSIVD Reagents for thyroid function hormone tests2023-12-11
    Product approval · Class 2체외 수인 23-4902 호
Show 49 more
  • MFDSIVD Reagents for thyroid function hormone tests2023-11-03
    Product approval · Class 2체외 수인 23-4842 호
  • MFDSClinical IVD strip for protein/lipid strip2023-10-24
    Product approval · Class 2체외 수인 23-4812 호
  • MFDSOther Reagents, classⅡ, for clinical chemistry2023-10-24
    Product approval · Class 2체외 수인 23-4811 호
  • MFDSOther Reagents, classⅡ, for clinical chemistry2023-10-18
    Product approval · Class 2체외 수인 23-4804 호
  • MFDSreagents for clinical enzymes2023-09-04
    Product approval · Class 2체외 수인 23-4749 호
  • MFDSChemiluminescence assay(CLIA) analyzer2023-08-16
    Product approval · Class 1체외 수신 23-1995 호
  • MFDSIVD Reagents for thyroid function hormone tests2023-08-11
    Product approval · Class 2체외 수인 23-4719 호
  • MFDSIVD reagents for tumor marker2023-06-26
    Product approval · Class 3체외 제허 23-714 호
  • MFDSIVD reagents for tumor marker2023-06-26
    Product approval · Class 3체외 제허 23-713 호
  • MFDSDry type clinical chemistry automated analyzer2023-04-04
    Product approval · Class 1체외 수신 23-872 호
  • MFDSChemiluminescence assay(CLIA) analyzer2022-10-06
    Product approval · Class 1체외 수신 22-1702 호
  • MFDSIVD reagent for infectious disease, immunological methodRevoked2022-04-29
    Product approval · Class 3체외 제허 22-275 호
  • MFDSTool for specimens2022-02-16
    Product approval · Class 1수신 22-239 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), immunological method2022-02-15
    Product approval · Class 3체외 제허 22-103 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), immunological method2022-02-15
    Product approval · Class 3체외 제허 22-101 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), immunological methodRevoked2021-08-12
    Product approval · Class 3체외 제허 21-688 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), immunological methodRevoked2021-06-23
    Product approval · Class 3체외 제허 21-514 호
  • MFDSTool for specimensRevoked2021-04-23
    Product approval · Class 1수신 21-697 호
  • MFDSIVD reagents for extracting nucleic acidsRevoked2021-01-22
    Product approval · Class 1체외 제신 21-84 호
  • MFDSSpecimen transport media2021-01-21
    Product approval · Class 1체외 제신 21-80 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), immunological method2020-12-18
    Product approval · Class 3체외 제허 20-1102 호
  • MFDSIVD reagents for tumor marker2020-12-11
    Product approval · Class 3체외 제허 20-1070 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 diagnostics2020-12-09
    Product approval · Class 3체외 제허 20-1059 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 diagnostics2020-11-10
    Product approval · Class 3체외 제허 20-949 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 diagnostics2020-07-17
    Product approval · Class 3체외 제허 20-582 호
  • MFDSIVD reagents for extracting nucleic acids2020-07-06
    Product approval · Class 1체외 제신 20-1031 호
  • MFDSImmunoabsorbance analyzer2020-06-29
    Product approval · Class 1체외 제신 20-986 호
  • MFDSIVD reagents for tumor marker2020-04-28
    Product approval · Class 3체외 제허 20-339 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), immunological method2020-03-30
    Product approval · Class 3체외 제허 20-229 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), immunological method2020-03-30
    Product approval · Class 3체외 제허 20-228 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2020-03-19
    Product approval · Class 1체외 제신 20-366 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2020-03-11
    Product approval · Class 1체외 제신 20-326 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 diagnostics2020-03-03
    Product approval · Class 3체외 제허 20-151 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2020-02-25
    Product approval · Class 1체외 제신 20-225 호
  • MFDSIVD reagents for tumor marker2020-02-18
    Product approval · Class 3체외 제허 20-126 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2020-02-18
    Product approval · Class 4체외 제허 20-125 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2019-11-15
    Product approval · Class 1체외 제신 19-1492 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2018-05-10
    Product approval · Class 1체외 제신 18-571 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), immunological method2018-04-06
    Product approval · Class 3체외 제허 18-235 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2018-03-05
    Product approval · Class 4체외 수허 18-81 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2018-03-05
    Product approval · Class 4체외 수허 18-80 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationaryRevoked2018-01-24
    Product approval · Class 1체외 제신 18-89 호
  • MFDSImmunoabsorbance analyzer2017-12-22
    Product approval · Class 1체외 제신 17-1437 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), immunological method2017-09-15
    Product approval · Class 3체외 제허 17-715 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2017-09-14
    Product approval · Class 1체외 제신 17-1079 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2017-01-25
    Product approval · Class 1체외 제신 17-84 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2016-10-26
    Product approval · Class 4체외 제허 16-778 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2016-08-29
    Product approval · Class 1체외 수신 16-2242 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological methodRevoked2014-05-14
    Product approval · Class 4체외 제허 14-1027 호
Not yet compiled: business overview · R&D. 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.

GC Medical Science Corporation18 shared

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

Boditech Med Inc.16 shared

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

SD BIOSENSOR INC.16 shared

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

OSANG HEALTHCARE CO.,LTD.14 shared

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

HUMASIS CO., LTD.12 shared

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

NanoenTek,Inc.12 shared

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

Precision Biosensor Inc.12 shared

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

Sugentech, Inc.11 shared

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

CALTH. Inc10 shared

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

RollingStone Co., Ltd.7 shared

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

GENEMATRIX INC.6 shared

KOSDAQ-listed biotech company developing molecular diagnostics with proprietary C-Tag technology and the NeoPlex product line.

Median Diagnostics Inc.6 shared

Founded in 1999 and listed on KONEX in 2017, Median Diagnostics develops and manufactures immunoassay, molecular, and point-of-care in vitro diagnostic kits for animal diseases.

Sources and updates

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

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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