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Medical DevicesKOSDAQ 9501302 approvals

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.

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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

2 Korean MFDS device approvals · 2010–2014

  • MFDSBandage, compression2014-08-06
    Product approval · Class 1서울 수신 14-2168 호
  • MFDSCompression system pump, sequential2010-11-26
    Product approval · Class 2수인 10-1288 호

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

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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.

DongKookPharmaceuticalCo.,Ltd.1 shared

KOSDAQ-listed comprehensive healthcare and pharmaceutical company behind the gum treatment Insadol and the wound-care ointment Madecassol.

HANS BIOMED CORPORATION1 shared

KOSDAQ-listed medical device company producing human tissue implants Bella Cell HD and SureFuse.

MEKICS Co., Ltd1 shared

KOSDAQ-listed critical-care medical device company manufacturing ventilators, the OmniOx respiratory therapy device series, and patient monitors.

JETEMA Co.,Ltd.90

Founded 2009, listed on KOSDAQ in 2019, JETEMA develops hyaluronic acid fillers, botulinum toxin biopharmaceuticals, and lifting threads.

i-SENS, Inc.90

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

SEJONG MEDICAL Co.Ltd.,85

Founded in 2010 and KOSDAQ-listed in 2018, Sejong Medical manufactures laparoscopic surgical instruments.

NanoenTek,Inc.85

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

Noul Co., Ltd.85

Founded in 2015 and listed on KOSDAQ in 2022, Noul develops the on-device AI diagnostic platform miLab™ for blood and cancer testing.

DRGEM CORPORATION85

KOSDAQ-listed manufacturer of diagnostic X-ray imaging systems and core components such as generators and tubes.

LabGenomics. Co., Ltd.85

KOSDAQ-listed molecular genetic diagnostics company providing NGS-based non-invasive prenatal testing (NIPT) under the MomGuard brand.

Corentec Co., Ltd.85

Founded in 2000 and KOSDAQ-listed in 2013, Corentec makes artificial joints; hip and knee implants exceed 85% of revenue.

OSTEONIC Co., Ltd.85

Established in 2012 and listed on KOSDAQ in 2018, Osteonic manufactures implants for the CMF, Trauma, Sports Medicine, and Spine categories.

Sources and updates

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

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