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Access Bio, Inc.

Official website

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

As of 2026-10-10, Access Bio, Inc. has 147 Korean MFDS device approvals, 4 PubMed-indexed papers on record (counted by the MAA Company Index from its own matching of public databases).

Price

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2002 and listed on KOSDAQ in 2013, Access Bio is a rapid diagnostic test (RDT) company for infectious diseases including malaria and COVID-19. It offers 11 malaria diagnostic products (including a Combo RDT and variant-malaria tests), five COVID-19 diagnostic products (COVID-19 IgG/IgM, COVID-19 antigen test, EZ Covid-19 IgG/IgM, COVID-19 Antigen Home test, and COVID-19 RT-PCR), an ovulation test kit (LH), hepatitis B and C and HIV antibody test kits, and a molecular pneumonia diagnostic kit. It obtained US FDA Emergency Use Authorization for five COVID-19 diagnostic products in 2020-2021, and according to Markets and Markets, the global in-vitro diagnostics market was valued at about USD 109 billion in 2025 and is projected to grow at a 7.6% CAGR through 2030.

Products & technology

  • Malaria diagnostic products (11 items, including Combo RDT)Diagnosis of falciparum and variant malaria
  • COVID-19 IgG/IgM, COVID-19 antigen test, EZ Covid-19 IgG/IgM, COVID-19 Antigen Home test, COVID-19 RT-PCRCOVID-19 antibody, antigen, and molecular testing
  • High-sensitivity malaria diagnostic kitDetection of asymptomatic, low-parasitemia infections
  • High-sensitivity COVID-19/flu combo kitSimultaneous COVID-19 and influenza detection
  • COVID-19/flu/RSV combo kitSimultaneous COVID-19, influenza, and RSV detection
  • Malaria mutation diagnostic kitDetection of malaria parasite mutations not identifiable by existing methods
  • Ovulation test kit (LH)Ovulation prediction via luteinizing hormone measurement
  • Hepatitis B antigen test, hepatitis C antibody test, HIV antibody testImmunochromatographic detection of infection
  • Pneumonia diagnostic kit (molecular)Real-time PCR simultaneous detection of 11 pathogens and 1 mutation across 3 tubes
  • H. pylori and clarithromycin-resistance point-mutation detection kit (molecular)Simultaneous detection of H. pylori infection and antibiotic resistance

Regulatory approvals

data.go.kr

147 Korean MFDS device approvals · 2010–2026

  • MFDSSubsidiary: 웰스바이오(주)IVD strip for endocrine self test2026-08-18
    Product approval · Class 2체외 제인 26-4754 호
  • MFDSSubsidiary: 웰스바이오(주)IVD strip for endocrine self test2026-05-22
    Product approval · Class 2체외 제인 26-4462 호
  • MFDSSubsidiary: 웰스바이오(주)reagents for clinical enzymes2025-09-09
    Product approval · Class 2체외 제인 25-4848 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for toxin, heavy metal and drugs of abuse2025-08-25
    Product approval · Class 2체외 제인 25-4787 호
  • MFDSSubsidiary: 웰스바이오(주)reagents for clinical enzymes2025-08-25
    Product approval · Class 2체외 제인 25-4786 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for total Hb test2025-08-20
    Product approval · Class 2체외 제인 25-4773 호
  • MFDSSubsidiary: 웰스바이오(주)Other instruments or devices, classⅠ, for other clinical chemistry2025-07-28
    Product approval · Class 1체외 제신 25-965 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for extracting nucleic acids2025-07-25
    Product approval · Class 1체외 제신 25-955 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for toxin, heavy metal and drugs of abuse2025-05-15
    Product approval · Class 2체외 제인 25-4418 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for toxin, heavy metal and drugs of abuse2025-05-15
    Product approval · Class 2체외 제인 25-4417 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for toxin, heavy metal and drugs of abuse2025-05-15
    Product approval · Class 2체외 제인 25-4416 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for toxin, heavy metal and drugs of abuse2025-05-15
    Product approval · Class 2체외 제인 25-4415 호
Show 68 more
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for toxin, heavy metal and drugs of abuse2025-05-15
    Product approval · Class 2체외 제인 25-4413 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for toxin, heavy metal and drugs of abuse2025-05-15
    Product approval · Class 2체외 제인 25-4412 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for extracting nucleic acids2025-04-30
    Product approval · Class 1체외 제신 25-561 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for extracting nucleic acids2025-03-19
    Product approval · Class 1체외 제신 25-338 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for toxin, heavy metal and drugs of abuse2025-02-25
    Product approval · Class 2체외 제인 25-4156 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for Infectious disease marker(Detection of low infectivity pathogen), immunological method2025-02-03
    Product approval · Class 2체외 제인 25-4096 호
  • MFDSSubsidiary: 웰스바이오(주)IVD strip for endocrine self test2025-01-03
    Product approval · Class 2체외 제인 25-4010 호
  • MFDSSubsidiary: 웰스바이오(주)Colorimeter for clinical use2024-12-16
    Product approval · Class 1체외 제신 24-1568 호
  • MFDSSubsidiary: 웰스바이오(주)Hemoglobin analyzer2024-11-25
    Product approval · Class 1체외 제인 24-1065 호
  • MFDSSubsidiary: 웰스바이오(주)Lancet, manually-operated, single-use2024-11-11
    Product approval · Class 2수인 24-604 호
  • MFDSSubsidiary: 웰스바이오(주)Blood collection unit, non-needle2024-04-08
    Product approval · Class 1수신 24-608 호
  • MFDSSubsidiary: 웰스바이오(주)Clinical IVD strip for endocrine, related to pregnant2024-03-07
    Product approval · Class 2체외 제인 24-253 호
  • MFDSSubsidiary: 웰스바이오(주)Capillary blood collection tube2024-03-06
    Product approval · Class 1수신 24-376 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 method2023-12-07
    Product approval · Class 3체외 제허 23-1116 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for extracting nucleic acids2023-11-24
    Product approval · Class 1체외 제신 23-1682 호
  • MFDSSubsidiary: 웰스바이오(주)IVD strip for endocrine self testRevoked2023-11-09
    Product approval · Class 2체외 제인 23-5248 호
  • MFDSSubsidiary: 웰스바이오(주)Hemoglobin analyzer2023-11-07
    Product approval · Class 1체외 제신 23-1608 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 diagnostics2023-11-03
    Product approval · Class 3체외 제허 23-1022 호
  • MFDSSubsidiary: 웰스바이오(주)IVD strip for endocrine self test2023-10-11
    Product approval · Class 2체외 제인 23-5151 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for extracting nucleic acids2023-07-31
    Product approval · Class 1체외 제신 23-1173 호
  • MFDSSubsidiary: 웰스바이오(주)IVD strip for endocrine self test2023-05-12
    Product approval · Class 2체외 제인 23-4710 호
  • MFDSSubsidiary: 웰스바이오(주)IVD strip for endocrine self test2023-04-12
    Product approval · Class 2체외 제인 23-4629 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 diagnostics2023-03-02
    Product approval · Class 3체외 제허 23-179 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for diabetes mellitus2023-01-27
    Product approval · Class 2체외 제인 23-4093 호
  • MFDSSubsidiary: 웰스바이오(주)Real-time gene amplificator, nucleic acid2023-01-11
    Product approval · Class 2체외 제인 23-4055 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 diagnostics2022-11-16
    Product approval · Class 3체외 제허 22-763 호
  • MFDSSubsidiary: (주)엑세스바이오코리아IVD 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 methodRevoked2022-11-07
    Product approval · Class 3체외 제허 22-742 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 method2022-10-17
    Product approval · Class 3체외 제허 22-689 호
  • MFDSSubsidiary: (주)엑세스바이오코리아IVD 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 methodRevoked2022-09-20
    Product approval · Class 3체외 제허 22-628 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 diagnostics2022-09-14
    Product approval · Class 3체외 제허 22-613 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 methodRevoked2022-08-03
    Product approval · Class 3체외 제허 22-518 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 methodRevoked2022-08-03
    Product approval · Class 3체외 제허 22-517 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 methodRevoked2022-07-27
    Product approval · Class 3체외 제허 22-490 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 diagnostics2022-06-30
    Product approval · Class 3체외 제허 22-419 호
  • MFDSSubsidiary: 웰스바이오(주)Extractor, nucleic acid2022-06-23
    Product approval · Class 1체외 제신 22-856 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 diagnostics2022-06-15
    Product approval · Class 3체외 제허 22-389 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for extracting nucleic acids2022-06-08
    Product approval · Class 1체외 제신 22-782 호
  • MFDSSubsidiary: 웰스바이오(주)Enzyme immunoassay/ELISA analyzer2022-05-17
    Product approval · Class 1체외 제신 22-694 호
  • MFDSSubsidiary: (주)엑세스바이오코리아IVD reagent for infectious disease, immunological methodRevoked2022-05-16
    Product approval · Class 3체외 제허 22-303 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 methodRevoked2022-04-27
    Product approval · Class 3체외 제허 22-263 호
  • MFDSSubsidiary: (주)엑세스바이오코리아IVD 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 methodRevoked2022-04-18
    Product approval · Class 3체외 제허 22-252 호
  • MFDSSubsidiary: (주)엑세스바이오코리아Tool for specimensRevoked2022-04-13
    Product approval · Class 1수신 22-631 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagent for infectious disease, immunological method2022-02-17
    Product approval · Class 3체외 제허 22-113 호
  • MFDSSubsidiary: (주)엑세스바이오코리아IVD 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 methodRevoked2022-01-11
    Product approval · Class 3체외 제허 22-15 호
  • MFDSSubsidiary: 웰스바이오(주)Other Reagents, classⅡ, for clinical chemistry2021-12-06
    Product approval · Class 2체외 제인 21-5005 호
  • MFDSSubsidiary: (주)엑세스바이오코리아IVD 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 methodRevoked2021-10-06
    Product approval · Class 3체외 제허 21-830 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 method2021-08-25
    Product approval · Class 3체외 제허 21-718 호
  • MFDSSubsidiary: 웰스바이오(주)Tool for specimensRevoked2021-07-28
    Product approval · Class 1수신 21-1410 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 method2021-05-27
    Product approval · Class 3체외 제허 21-419 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 methodRevoked2020-12-21
    Product approval · Class 3체외 제허 20-1114 호
  • MFDSSubsidiary: (주)엑세스바이오코리아IVD 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 methodRevoked2020-11-26
    Product approval · Class 3체외 제허 20-999 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 method2020-11-05
    Product approval · Class 3체외 제허 20-934 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for extracting nucleic acids2020-08-20
    Product approval · Class 1체외 제신 20-1252 호
  • MFDSSubsidiary: 웰스바이오(주)General calibrators, controls or standards, classⅡ, for clinical chemistry2020-08-11
    Product approval · Class 2체외 제인 20-4733 호
  • MFDSSubsidiary: 웰스바이오(주)General calibrators, controls or standards, classⅡ, for clinical chemistry2020-08-04
    Product approval · Class 2체외 제인 20-4701 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for total Hb test2020-07-23
    Product approval · Class 2체외 제인 20-4657 호
  • MFDSSubsidiary: (주)엑세스바이오코리아IVD 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 methodRevoked2020-07-03
    Product approval · Class 3체외 제허 20-536 호
  • MFDSSubsidiary: 웰스바이오(주)Capillary blood collection tube2020-05-20
    Product approval · Class 1수신 20-1180 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 method2020-05-14
    Product approval · Class 3체외 제허 20-363 호
  • MFDSSubsidiary: 웰스바이오(주)reagents for clinical enzymes2020-04-13
    Product approval · Class 2체외 수허 20-70 호
  • MFDSSubsidiary: 웰스바이오(주)Clinical IVD strip for protein/lipid strip2020-04-10
    Product approval · Class 2체외 제인 20-4275 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 diagnostics2020-04-08
    Product approval · Class 3체외 제허 20-261 호
  • MFDSSubsidiary: 웰스바이오(주)IVD 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 diagnostics2020-03-18
    Product approval · Class 3체외 제허 20-197 호
  • MFDSSubsidiary: 웰스바이오(주)Capillary blood collection tube2020-03-18
    Product approval · Class 1수신 20-689 호
  • MFDSSubsidiary: 웰스바이오(주)General Calibrators, controls or standards, classⅡ, for clinical immunology, not a component of specific kit, wide use2020-03-18
    Product approval · Class 2체외 제신 20-350 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for extracting nucleic acids2020-03-16
    Product approval · Class 1체외 제신 20-339 호
  • MFDSSubsidiary: 웰스바이오(주)IVD reagents for diabetes mellitus2020-02-24
    Product approval · Class 2체외 제인 20-4152 호
  • MFDSSubsidiary: 웰스바이오(주)General calibrators, controls or standards, classⅠ, for clinical chemistryRevoked2020-02-04
    Product approval · Class 1체외 제신 20-141 호

Showing the 80 most recent of 147 records.

R&D and key agreements

Source: DART corporate disclosure

고민감도 말라리아 진단키트 · 말라리아 · 미국 판매허가 완료 · Improved-sensitivity product for detecting asymptomatic, low-parasitemia cases

말라리아 돌연변이 진단키트 · 말라리아 기생충 돌연변이 · 임상진행중 · Developing a product to detect mutations that existing methods struggle to identify

폐렴진단키트(분자진단) · 폐렴 · Real-time PCR simultaneous detection of 11 pathogens and 1 mutation in 3 tubes

헬리코박터 내성 동시검출키트(분자진단) · 헬리코박터 감염 · Simultaneous real-time PCR diagnosis of H. pylori and clarithromycin-resistance point mutations

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 37 more patents

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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.24 shared

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

SD BIOSENSOR INC.23 shared

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

GC Medical Science Corporation21 shared

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

OSANG HEALTHCARE CO.,LTD.19 shared

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

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.

RollingStone Co., Ltd.13 shared

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

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.

Sugentech, Inc.12 shared

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

CALTH. Inc12 shared

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

Precision Biosensor Inc.11 shared

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

PCL. Inc11 shared

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

DONG-A ST CO.,LTD10 shared

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

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

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