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Medical DevicesKOSDAQ 33581091 approvals

Precision Biosensor Inc.

Official website

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

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Business overview

Source: DART corporate disclosure

Founded in 2009 and listed on KOSDAQ in 2020, Precision Biosensor is an in-vitro diagnostics (IVD) company. It produces the Exdia TRF time-resolved fluorescence immunodiagnostic analyzer and cartridges, gold-absorbance analyzers, the rapid visual diagnostic product PBCheck, and clinical chemistry products Exdia PT10/PT10S (human) and PT10V (veterinary), while subsidiary Nano-Ditech sells Fluoro-Checker™ and Nano-Checker™. It manufactures 22 Exdia TRF fluorescence immunoassay reagents and 12 Fluoro-Checker™ TRF reagents, with its Eu fluorescent label enabling detection sensitivity up to 300 times higher than colorimetric gold-particle absorbance.

Products & technology

  • Exdia TRFtime-resolved fluorescence immunodiagnostic analyzer and cartridges
  • PBCheckrapid visual diagnostic cartridge
  • Exdia PT10/PT10Sclinical chemistry diagnostics (human)
  • Exdia PT10Vclinical chemistry diagnostics (veterinary)
  • Fluoro-Checker™TRF immunodiagnostic analyzer/cartridges (Nano-Ditech product)
  • Nano-Checker™gold-absorbance diagnostic analyzer/cartridges (Nano-Ditech product)
  • Exdia Troponin I / NT-proBNP / D-dimercardiovascular disease diagnostics
  • Exdia Influenza A+B / COVID-19 Aginfectious disease diagnostics
  • Exdia iFOB / β-hCG / Vitamin Doncology/hormone/vitamin diagnostics

Regulatory approvals

data.go.kr

91 Korean MFDS device approvals · 2012–2026

  • MFDSIVD reagents for diabetes mellitus2026-08-03
    Product approval · Class 2체외 제인 26-4711 호
  • MFDSClinical IVD strip for protein/lipid strip2026-06-23
    Product approval · Class 2체외 제인 26-4572 호
  • MFDSIVD reagents for diabetes mellitus2026-06-02
    Product approval · Class 2체외 제인 26-4486 호
  • MFDSCapillary blood collection tube2026-03-26
    Product approval · Class 1수신 26-642 호
  • MFDSIVD reagents for bone and mineral metabolite measurement test2026-02-04
    Product approval · Class 2체외 제인 26-4104 호
  • MFDSIVD reagents for inflammatory tests2026-02-04
    Product approval · Class 2체외 제인 26-4103 호
  • MFDSIVD reagents for infectious inflammatory tests2026-02-04
    Product approval · Class 2체외 제인 26-4102 호
  • MFDSIVD reagents for inflammatory tests2026-01-20
    Product approval · Class 2체외 제인 26-4059 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-12-31
    Product approval · Class 2체외 제인 25-5002 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-11-24
    Product approval · Class 2체외 제인 25-5094 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-11-19
    Product approval · Class 2체외 제인 25-5075 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-11-18
    Product approval · Class 2체외 제인 25-5071 호
Show 68 more
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-10-14
    Product approval · Class 2체외 제인 25-4945 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-10-13
    Product approval · Class 2체외 제인 25-4940 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2025-10-02
    Product approval · Class 1체외 제신 25-1329 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-09-30
    Product approval · Class 2체외 제인 25-4917 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-09-16
    Product approval · Class 2체외 제인 25-4878 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-09-16
    Product approval · Class 2체외 제인 25-4877 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-09-11
    Product approval · Class 2체외 제인 25-4861 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2025-09-11
    Product approval · Class 2체외 제인 25-4860 호
  • MFDSIVD reagents for diabetes mellitus2025-08-29
    Product approval · Class 2체외 제인 25-4809 호
  • MFDSIVD Reagents for thyroid function hormone tests2025-06-05
    Product approval · Class 2체외 제인 25-4491 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 method2025-05-22
    Product approval · Class 3체외 수허 25-82 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 method2025-05-14
    Product approval · Class 3체외 제허 25-317 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 method2025-04-28
    Product approval · Class 3체외 제허 25-274 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2024-12-23
    Product approval · Class 1체외 제신 24-1613 호
  • MFDSChemiluminescence assay(CLIA) analyzer2024-09-30
    Product approval · Class 1체외 제신 24-1205 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 method2024-09-03
    Product approval · Class 3체외 제허 24-602 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 methodRevoked2024-09-03
    Product approval · Class 3체외 제허 24-601 호
  • MFDSIVD Reagents for thyroid function hormone tests2024-01-22
    Product approval · Class 2체외 제인 24-86 호
  • MFDSIVD Reagents for thyroid function hormone tests2024-01-18
    Product approval · Class 2체외 제인 24-66 호
  • MFDSCapillary blood collection tube2023-06-23
    Product approval · Class 1수신 23-1538 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 method2023-05-22
    Product approval · Class 3체외 제허 23-603 호
  • MFDSIVD reagents for extracting nucleic acids2023-05-03
    Product approval · Class 1체외 제신 23-766 호
  • MFDSIVD reagent for infectious disease, immunological method2023-01-30
    Product approval · Class 3체외 제허 23-67 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 method2022-11-21
    Product approval · Class 3체외 제허 22-779 호
  • MFDSClinical IVD strip for protein/lipid strip2022-07-21
    Product approval · Class 2체외 제인 22-4542 호
  • MFDSClinical IVD strip for protein/lipid strip2022-07-13
    Product approval · Class 2체외 제인 22-4528 호
  • MFDSIVD reagents for diabetes mellitus2022-07-13
    Product approval · Class 2체외 제인 22-4527 호
  • MFDSClinical IVD strip for protein/lipid strip2022-07-13
    Product approval · Class 2체외 제인 22-4526 호
  • MFDSClinical IVD strip for protein/lipid strip2022-07-13
    Product approval · Class 2체외 제인 22-4525 호
  • MFDSSpectrophotometer for clinical use2022-06-13
    Product approval · Class 1체외 제신 22-803 호
  • MFDSIVD reagents for cardiac marker2022-01-17
    Product approval · Class 3체외 제허 22-28 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 method2021-12-30
    Product approval · Class 3체외 제허 21-1055 호
  • MFDSTool for specimens2021-11-24
    Product approval · Class 1수신 21-2121 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 method2021-08-10
    Product approval · Class 3체외 제허 21-674 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 method2021-08-03
    Product approval · Class 3체외 제허 21-658 호
  • MFDSClinical IVD strip for protein/lipid stripRevoked2021-05-27
    Product approval · Class 2체외 제인 21-4455 호
  • MFDSClinical IVD strip for protein/lipid stripRevoked2021-05-24
    Product approval · Class 2체외 제인 21-4442 호
  • MFDSClinical IVD strip for protein/lipid stripRevoked2021-05-24
    Product approval · Class 2체외 제인 21-4440 호
  • MFDSClinical IVD strip for protein/lipid stripRevoked2021-05-21
    Product approval · Class 2체외 제인 21-4436 호
  • MFDSClinical IVD strip for protein/lipid stripRevoked2021-05-21
    Product approval · Class 2체외 제인 21-4435 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 method2021-05-06
    Product approval · Class 3체외 제허 21-350 호
  • MFDSIVD reagents for diagnostic blood coagulation test2021-04-20
    Product approval · Class 3체외 제허 21-306 호
  • MFDSTool for specimens2021-02-25
    Product approval · Class 1수신 21-319 호
  • MFDSTool for specimens2020-12-24
    Product approval · Class 1수신 20-2870 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 20-1104 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 methodRevoked2020-11-06
    Product approval · Class 3체외 제허 20-943 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 method2020-09-10
    Product approval · Class 3체외 제허 20-795 호
  • MFDSGeneral calibrators, controls or standards, classⅡ, for clinical chemistry2020-06-18
    Product approval · Class 2체외 제인 20-4540 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 method2020-06-09
    Product approval · Class 3체외 제허 20-458 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 method2020-06-05
    Product approval · Class 3체외 제허 20-446 호
  • MFDSIVD reagents for inflammatory testsRevoked2020-03-12
    Product approval · Class 2체외 제인 20-4198 호
  • MFDSIVD reagents for bone and mineral metabolite measurement test2019-11-05
    Product approval · Class 2체외 제인 19-4904 호
  • MFDSIVD reagents for diagnostic blood coagulation test2019-10-23
    Product approval · Class 3체외 제허 19-669 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 method2019-10-18
    Product approval · Class 3체외 제허 19-658 호
  • MFDSIVD reagents for cardiac marker2018-07-30
    Product approval · Class 3체외 제허 18-544 호
  • MFDSIVD reagents for cardiac marker2018-07-30
    Product approval · Class 3체외 제허 18-543 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 methodRevoked2018-04-18
    Product approval · Class 3체외 제허 18-271 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2018-04-04
    Product approval · Class 2체외 제인 18-4260 호
  • MFDSIVD reagents for fecal occult blood test2018-04-02
    Product approval · Class 2체외 제인 18-4251 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein testsRevoked2018-02-05
    Product approval · Class 2체외 제인 18-4087 호
  • MFDSIVD reagents for infectious inflammatory tests2017-12-11
    Product approval · Class 2체외 제인 17-4950 호
  • MFDSIVD reagents for diagnostic blood coagulation testRevoked2017-09-14
    Product approval · Class 3체외 제허 17-707 호
  • MFDSIVD reagents for cardiac marker2017-09-14
    Product approval · Class 3체외 제허 17-706 호
  • MFDSIVD reagents for cardiac markerRevoked2017-09-14
    Product approval · Class 3체외 제허 17-705 호
  • MFDSTool for specimensRevoked2017-09-12
    Product approval · Class 1제신 17-1071 호
  • MFDSIVD reagents for infectious inflammatory testsRevoked2017-08-22
    Product approval · Class 2체외 제인 17-4662 호
  • MFDSIVD reagents for cardiac markerRevoked2017-05-24
    Product approval · Class 3체외 제허 17-345 호
  • MFDSFluorimetric immunoassay analyzer(FIA), stationary2017-02-01
    Product approval · Class 1체외 제신 17-103 호

Showing the 80 most recent of 91 records.

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.

SD BIOSENSOR INC.20 shared

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

Boditech Med Inc.19 shared

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

GC Medical Science Corporation18 shared

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

OSANG HEALTHCARE CO.,LTD.17 shared

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

Sugentech, Inc.16 shared

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

HUMASIS CO., LTD.13 shared

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

CALTH. Inc12 shared

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

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.

PCL. Inc12 shared

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

GENEMATRIX INC.8 shared

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

i-SENS, Inc.8 shared

Founded in 2000 and KOSDAQ-listed in 2013, i-SENS makes blood glucose monitors and point-of-care testing devices.

RollingStone Co., Ltd.7 shared

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

Sources and updates

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

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