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Medical DevicesKOSPI 37774028 approvals

BioNote, Inc.

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Founded in 2003 and KOSPI-listed in 2022, BioNote develops and manufactures animal diagnostic reagents and bio-content materials.

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Business overview

Source: DART corporate disclosure

Founded in 2003 and listed on KOSPI in 2022, BioNote is an animal diagnostic reagent and bio-content company. It sells rapid immunochemical diagnostics under the BIONOTE Rapid brand, fluorescence immunoassay products under Vcheck F, enzyme immunoassay diagnostics under BIONOTE ELISA, and bio-content semi-finished products and raw materials such as antigens, antibodies, and enzymes. It distributes through distributors and affiliates in each country, and is expanding into molecular and biochemical diagnostics while growing its bio-content business by supplying raw materials for human in-vitro diagnostic (IVD) reagents.

Products & technology

  • Rapid immunochemical diagnostics (BIONOTE Rapid)Rapid diagnostic testing for animals
  • Fluorescence immunoassay (Vcheck F)Fluorescence immunochemical diagnostics for animals
  • Enzyme immunoassay diagnostics (BIONOTE ELISA)Enzyme immunoassay diagnostics for animals
  • Bio-content semi-finished products and raw materials (antigens, antibodies, enzymes)Raw material supply applicable to human in-vitro diagnostic (IVD) reagents

Regulatory approvals

data.go.kr

28 Korean MFDS device approvals · 2014–2022

  • 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 method2022-10-20
    Product approval · Class 3체외 제허 22-704 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), immunological method2022-03-15
    Product approval · Class 3체외 제허 22-176 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 method2021-12-23
    Product approval · Class 3체외 제허 21-1036 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 method2021-09-07
    Product approval · Class 3체외 제허 21-745 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 method2021-08-26
    Product approval · Class 3체외 제허 21-721 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 method2021-08-18
    Product approval · Class 3체외 제허 21-698 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 method2020-05-21
    Product approval · Class 3체외 제허 20-386 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 method2020-05-21
    Product approval · Class 3체외 제허 20-385 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2019-03-19
    Product approval · Class 4체외 제허 19-167 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 method2017-10-10
    Product approval · Class 3체외 제허 17-773 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 method2017-09-25
    Product approval · Class 3체외 제허 17-741 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 method2017-09-25
    Product approval · Class 3체외 제허 17-738 호
Show 16 more
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2017-04-19
    Product approval · Class 4체외 제허 17-276 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 method2017-01-25
    Product approval · Class 3체외 제허 17-76 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 method2017-01-25
    Product approval · Class 3체외 제허 17-77 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 method2017-01-23
    Product approval · Class 3체외 제허 17-67 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2017-01-23
    Product approval · Class 4체외 제허 17-66 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 method2017-01-23
    Product approval · Class 3체외 제허 17-65 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), immunological method2017-01-23
    Product approval · Class 3체외 제허 17-64 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2017-01-23
    Product approval · Class 4체외 제허 17-63 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2017-01-23
    Product approval · Class 4체외 제허 17-62 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 method2017-01-19
    Product approval · Class 3체외 제허 17-55 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 method2017-01-19
    Product approval · Class 3체외 제허 17-53 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 method2017-01-19
    Product approval · Class 3체외 제허 17-52 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 method2017-01-19
    Product approval · Class 3체외 제허 17-54 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 method2017-01-06
    Product approval · Class 3체외 제허 17-26 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological methodRevoked2014-12-11
    Product approval · Class 4제허 14-3000 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein testsRevoked2014-12-09
    Product approval · Class 2제허 14-2937 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.

OSANG HEALTHCARE CO.,LTD.3 shared

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

NanoenTek,Inc.3 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.3 shared

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

Boditech Med Inc.3 shared

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

GC Medical Science Corporation3 shared

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

SD BIOSENSOR INC.3 shared

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

PCL. Inc2 shared

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

Precision Biosensor Inc.2 shared

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

Sugentech, Inc.2 shared

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

Micro Digital Co., Ltd.2 shared

KOSDAQ-listed bioprocess and biomedical company supplying the CELBIC single-use cell culture system and the DxBIC automated analysis system.

CALTH. Inc2 shared

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

SLSBio(Specialty Lab Solution Bio) Co., Ltd1 shared

Founded 2007, KOSDAQ-listed 2023, SLSBio provides pharmaceutical quality control, drug development support, and in vitro diagnostics.

Sources and updates

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

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