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Biotech & Drug DiscoveryKOSPI 137310451 approvals

SD BIOSENSOR INC.

Official website

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

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Business overview

Source: DART corporate disclosure

Founded in 2010 and listed on KOSPI in 2021, SD Biosensor is an in-vitro diagnostics (IVD) medical device and reagent company. It combines immunoassay, molecular, and clinical chemistry technology platforms into a portfolio addressing infectious disease and chronic disease diagnostics, with products including the STANDARD Q antigen/antibody test kits. Based on global certifications such as WHO PQ, CE-IVD/IVDR, and FDA, it supplies both commercial markets and international public procurement channels such as the Global Fund and UNICEF.

Products & technology

  • STANDARD Q antigen/antibody test kitIn-vitro diagnostic test for infectious diseases including COVID-19

Regulatory approvals

data.go.kr · openFDA

447 Korean MFDS device approvals · 2007–2026 / 4 US FDA 510(k) · 2015–2017

  • MFDSChemiluminescence assay(CLIA) analyzer2026-08-14
    Product approval · Class 1체외 제신 26-1015 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 method2026-08-05
    Product approval · Class 3체외 제허 26-597 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2026-07-28
    Product approval · Class 2체외 제인 26-4695 호
  • MFDSCentrifugal clinical chemistry automated analyser2026-07-24
    Product approval · Class 1체외 수신 26-1645 호
  • MFDSUrine chemistry analyzer, (semi-)automated2026-07-03
    Product approval · Class 1체외 수신 26-1476 호
  • MFDSUrine chemistry analyzer, (semi-)automated2026-07-03
    Product approval · Class 1체외 수신 26-1475 호
  • MFDSIVD reagents for vitamin tests2026-06-16
    Product approval · Class 2체외 제인 26-4526 호
  • MFDSIVD reagents for diabetes mellitus2026-05-19
    Product approval · Class 2체외 수인 26-4351 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2026-05-19
    Product approval · Class 2체외 제인 26-4444 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 method2026-05-15
    Product approval · Class 3체외 제허 26-366 호
  • MFDSHematology analyzer, glycohemoglobin2026-05-14
    Product approval · Class 1체외 수신 26-1038 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2026-05-11
    Product approval · Class 2체외 제인 26-4419 호
Show 68 more
  • MFDSIVD Reagents for thyroid function hormone tests2026-04-30
    Product approval · Class 2체외 제인 26-4389 호
  • MFDSIVD reagents for kidney metabolite measurement test2026-04-27
    Product approval · Class 2체외 제인 26-4369 호
  • MFDSIVD reagents for diabetes mellitus2026-04-22
    Product approval · Class 2체외 제인 26-4355 호
  • MFDSIVD reagents for bone and mineral metabolite measurement test2026-04-20
    Product approval · Class 2체외 제인 26-4343 호
  • MFDSIVD reagents for diabetes mellitus2026-04-16
    Product approval · Class 2체외 수인 26-4261 호
  • MFDSIVD Reagents for thyroid function hormone tests2026-04-09
    Product approval · Class 2체외 제인 26-4324 호
  • MFDSIVD Reagents for thyroid function hormone tests2026-04-09
    Product approval · Class 2체외 제인 26-4323 호
  • MFDSIVD Reagents for thyroid function hormone tests2026-04-09
    Product approval · Class 2체외 제인 26-4322 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2026-04-09
    Product approval · Class 2체외 제인 26-4320 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2026-03-16
    Product approval · Class 2체외 제인 26-4241 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2026-03-13
    Product approval · Class 2체외 제인 26-4239 호
  • MFDSIVD Reagents for thyroid function hormone tests2026-03-12
    Product approval · Class 2체외 제인 26-4228 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2026-03-12
    Product approval · Class 2체외 제인 26-4226 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2026-03-12
    Product approval · Class 2체외 제인 26-4225 호
  • MFDSHematology analyzer, glycohemoglobin2026-02-24
    Product approval · Class 1체외 수신 26-428 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 method2026-02-23
    Product approval · Class 3체외 제허 26-144 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 method2026-02-02
    Product approval · Class 3체외 제허 26-98 호
  • MFDSIVD reagents for infectious inflammatory tests2026-01-30
    Product approval · Class 2체외 제인 26-4093 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2026-01-28
    Product approval · Class 2체외 제인 26-4089 호
  • MFDSContinuous glucose monitoring systems, self-testing, in vivo2026-01-08
    Product approval · Class 3제허 26-21 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), molecular diagnostics2025-12-29
    Product approval · Class 3체외 제허 25-867 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), molecular diagnostics2025-12-16
    Product approval · Class 3체외 제허 25-842 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), molecular diagnostics2025-11-18
    Product approval · Class 3체외 제허 25-776 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), molecular diagnostics2025-11-11
    Product approval · Class 3체외 제허 25-760 호
  • MFDSIVD reagents for Infectious disease marker(Detection of low infectivity pathogen), nucleic acid test2025-09-16
    Product approval · Class 2체외 제인 25-4876 호
  • MFDSIVD reagents for allergy test2025-09-15
    Product approval · Class 2체외 제인 25-4873 호
  • MFDSIVD reagents for cardiac marker2025-09-10
    Product approval · Class 3체외 제허 25-621 호
  • MFDSIVD reagents for cardiac markerRevoked2025-09-10
    Product approval · Class 3체외 제허 25-620 호
  • MFDSGeneral Calibrators, controls or standards, classⅢ, for clinical immunology, not a component of specific kit, wide use2025-09-08
    Product approval · Class 3체외 제허 25-616 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein testsRevoked2025-09-03
    Product approval · Class 2체외 제인 25-4818 호
  • MFDSIVD Reagents for thyroid function hormone testsRevoked2025-09-03
    Product approval · Class 2체외 제인 25-4817 호
  • MFDSIVD Reagents for thyroid function hormone testsRevoked2025-09-03
    Product approval · Class 2체외 제인 25-4816 호
  • MFDSCapillary blood collection tube2025-08-27
    Product approval · Class 1수신 25-1864 호
  • MFDSCapillary blood collection tube2025-08-25
    Product approval · Class 1수신 25-1840 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 method2025-08-08
    Product approval · Class 3체외 제허 25-545 호
  • MFDSIVD reagents for Infectious disease marker(Drug resistant microorganism)2025-08-06
    Product approval · Class 3체외 제허 25-537 호
  • MFDSCapillary blood collection tube2025-07-25
    Product approval · Class 1수신 25-1609 호
  • MFDSCapillary blood collection tube2025-07-22
    Product approval · Class 1수신 25-1585 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), molecular diagnostics2025-07-21
    Product approval · Class 3체외 제허 25-489 호
  • MFDSTool for specimens2025-07-17
    Product approval · Class 1수신 25-1547 호
  • MFDSIVD reagents for tumor marker2025-07-16
    Product approval · Class 3체외 제허 25-472 호
  • MFDSIVD reagents for cardiac marker2025-07-15
    Product approval · Class 3체외 제허 25-468 호
  • MFDSIVD reagents for tumor marker2025-07-15
    Product approval · Class 3체외 제허 25-467 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein testsRevoked2025-07-09
    Product approval · Class 2체외 제인 25-4609 호
  • MFDSIVD reagents for tumor marker2025-07-07
    Product approval · Class 3체외 제허 25-445 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), molecular diagnostics2025-07-03
    Product approval · Class 3체외 제허 25-438 호
  • MFDSIVD reagents for tumor marker2025-06-26
    Product approval · Class 3체외 제허 25-416 호
  • MFDSIVD reagents for cardiac marker2025-06-26
    Product approval · Class 3체외 제허 25-415 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein testsRevoked2025-06-23
    Product approval · Class 2체외 제인 25-4549 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein testsRevoked2025-06-23
    Product approval · Class 2체외 제인 25-4548 호
  • MFDSIVD reagents for infectious inflammatory testsRevoked2025-06-20
    Product approval · Class 2체외 제인 25-4546 호
  • MFDSIVD reagents for tumor marker2025-06-16
    Product approval · Class 3체외 제허 25-391 호
  • MFDSIVD reagents for cardiac marker2025-06-16
    Product approval · Class 3체외 제허 25-390 호
  • MFDSIVD reagents for anemia testRevoked2025-06-13
    Product approval · Class 2체외 제인 25-4511 호
  • MFDSIVD Reagents for thyroid function hormone testsRevoked2025-06-12
    Product approval · Class 2체외 제인 25-4507 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein testsRevoked2025-06-12
    Product approval · Class 2체외 제인 25-4506 호
  • MFDSLancet, automatic, single-use2025-04-23
    Product approval · Class 2수인 25-4246 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), molecular diagnosticsRevoked2025-04-17
    Product approval · Class 3체외 제허 25-256 호
  • MFDSIVD strip for endocrine self test2025-04-14
    Product approval · Class 2체외 수인 25-4230 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), molecular diagnostics2025-04-02
    Product approval · Class 3체외 제허 25-217 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 method2025-01-13
    Product approval · Class 3체외 제허 25-24 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 method2025-01-10
    Product approval · Class 3체외 제허 25-18 호
  • MFDSChemiluminescence assay(CLIA) analyzer2024-11-26
    Product approval · Class 1체외 제신 24-1470 호
  • MFDSChemiluminescence assay(CLIA) analyzer2024-11-26
    Product approval · Class 1체외 제신 24-1469 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, immunological method2024-11-12
    Product approval · Class 4체외 제허 24-780 호
  • MFDSIVD Reagents for pregnancy/childbirth hormone and protein tests2024-09-30
    Product approval · Class 2체외 제인 24-901 호
  • MFDSIVD reagents for anemia test2024-09-30
    Product approval · Class 2체외 제인 24-900 호
  • MFDSIVD strip for glucose self test2024-09-12
    Product approval · Class 3체외 제허 24-633 호

Showing the 80 most recent of 451 records.

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Companies approved for the same productsBiotech & Drug Discovery

Ranked by how many MFDS product categories overlap. Not a ranking — a pointer to where to look.

GC Medical Science Corporation40 shared

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

Boditech Med Inc.39 shared

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

OSANG HEALTHCARE CO.,LTD.35 shared

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

Sugentech, Inc.26 shared

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

HUMASIS CO., LTD.25 shared

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

i-SENS, Inc.22 shared

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

NanoenTek,Inc.20 shared

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

Precision Biosensor Inc.20 shared

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

CALTH. Inc17 shared

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

PCL. Inc16 shared

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

RollingStone Co., Ltd.15 shared

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

GENEMATRIX INC.13 shared

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

Sources and updates

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

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