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Medical DevicesKOSPI 137310464 approvals

SD BIOSENSOR INC.

Official website

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

As of 2026-10-10, SD BIOSENSOR INC. has 460 Korean MFDS device approvals, 4 US FDA clearances/approvals, 6 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 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

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

  • MFDSIVD reagents for toxin, heavy metal and drugs of abuse2026-09-22
    Product approval · Class 2체외 수인 26-4677 호
  • MFDSIVD reagents for endocrine hormone and peptide2026-09-22
    Product approval · Class 2체외 제인 26-4876 호
  • MFDSIVD reagents for toxin, heavy metal and drugs of abuse2026-09-22
    Product approval · Class 2체외 수인 26-4675 호
  • MFDSBlood collection unit, non-needle2026-09-18
    Product approval · Class 1수신 26-2145 호
  • MFDSBlood collection unit, non-needle2026-09-18
    Product approval · Class 1수신 26-2144 호
  • MFDSreagents for clinical enzymes2026-09-17
    Product approval · Class 2체외 수인 26-4662 호
  • MFDSBlood glucose meter for self test2026-09-16
    Product approval · Class 3체외 제허 26-705 호
  • MFDSIVD reagents for vitamin tests2026-09-11
    Product approval · Class 2체외 제인 26-4834 호
  • MFDSBlood glucose meter for self test2026-09-09
    Product approval · Class 3체외 제허 26-686 호
  • MFDSIVD reagents for urine chemistry2026-08-27
    Product approval · Class 2체외 수인 26-4611 호
  • MFDSIVD reagents for urine chemistry2026-08-27
    Product approval · Class 2체외 수인 26-4610 호
  • MFDSIVD reagents for urine chemistry2026-08-27
    Product approval · Class 2체외 수인 26-4609 호
Show 68 more
  • MFDSBlood glucose meter for self test2026-08-26
    Product approval · Class 3체외 제허 26-650 호
  • 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
  • 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

Showing the 80 most recent of 464 records.

Key disclosures

KRX KIND via OpenDART

Publications

PubMed · affiliation-matched

Patents

KIPRIS · applicant-matched
Show 145 more patents

AI reads

MAA server logs · IP-verified
230
Times AI engines pulled SD BIOSENSOR INC.'s records

Pulled records become part of each AI's index and keep feeding its answers. When an AI cites from that index, nothing reaches our server — so actual citations are uncounted here and exceed this number.

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Times an AI needed something not yet in its index and fetched this page fresh while answering. Citations served from the index leave no trace here.

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Queries from users who connected this index to their own AI.

14
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Last 7 days
174
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Last 30 days
230
live 2
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  • OpenAIOAI-SearchBot186
  • GoogleGoogleOther29
  • PerplexityPerplexityBot10
  • AnthropicClaudeBot2
  • MicrosoftBingbot1

Measured since Aug 25, 2026 · 5 AI engines · last read Oct 8, 2026

User-agent strings can be forged, so we do not count them at face value. We count only requests matched against vendor-published IP ranges, or confirmed by forward-verified reverse DNS. MCP queries are actual calls to this index's tool endpoint.

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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.41 shared

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

GC Medical Science Corporation41 shared

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

OSANG HEALTHCARE CO.,LTD.35 shared

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

HUMASIS CO., LTD.26 shared

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

Sugentech, Inc.26 shared

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

Access Bio, Inc.23 shared

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

DONG-A ST CO.,LTD23 shared

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

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.21 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.

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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