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Medical DevicesKOSPI 37774028 approvals

BioNote, Inc.

Official website

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

As of 2026-10-10, BioNote, Inc. has 28 Korean MFDS device approvals, 10 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

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Market cap

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

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 43 more patents

AI reads

MAA server logs · IP-verified
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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.

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.

Boditech Med Inc.3 shared

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

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.

OSANG HEALTHCARE CO.,LTD.3 shared

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

GC Medical Science Corporation3 shared

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

COSMAX BTI, INC.3 shared

Founded in 1992 and listed on KOSPI in 2006, COSMAX BTI is the COSMAX Group holding company overseeing health food and cosmetics affiliates.

DONG-A ST CO.,LTD3 shared

Dong-A ST, spun off from Dong-A Socio Holdings in 2013 and KOSPI-listed, makes prescription drugs like Growtropin, Stillen, and Bacchus.

SD BIOSENSOR INC.3 shared

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

Precision Biosensor Inc.2 shared

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

PCL. Inc2 shared

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

Access Bio, Inc.2 shared

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

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.

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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