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Medical DevicesKOSDAQ 08465063 approvals

LabGenomics. Co., Ltd.

Official website

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

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Market cap

Business overview

Source: DART corporate disclosure

Founded in 2002 and listed on KOSDAQ in 2014, LabGenomics is a molecular genetic diagnostics company. It offers the NGS-based non-invasive prenatal testing (NIPT) products MomGuard, MomGuard Advance, and MomGuard Advance Plus; the newborn screening tests AngpangGuard and IMS plus; the miscarriage-cause analysis test Pre-MomGuard; and the LabGun COVID-19 Assay diagnostic kit. MomGuard Advance Plus analyzes up to 127 types of chromosomal abnormalities and is offered through a network of more than 3,000 medical institutions and 200 obstetrics/gynecology specialty hospitals in Korea, while the LabGun COVID-19 Assay, with a 2.5-hour turnaround and 100% sensitivity/specificity, received U.S. FDA Emergency Use Authorization in April 2020.

Products & technology

  • MomGuardNGS-based non-invasive prenatal test (NIPT)
  • MomGuard Advance PlusPremium NIPT analyzing up to 127 types of chromosomal abnormalities
  • AngpangGuardNGS-based newborn screening test for developmental-disorder-related chromosomal abnormalities
  • IMS plusAnalysis of pathogenic variants in 27 genes linked to hereditary metabolic disease and congenital hearing loss
  • Pre-MomGuardNGS-based chromosomal analysis test for miscarriage cause
  • LabGun COVID-19 AssayReal-time PCR-based COVID-19 diagnostic kit

Regulatory approvals

data.go.kr

63 Korean MFDS device approvals · 2014–2025

  • MFDSIVD reagents for toxin, heavy metal and drugs of abuseRevoked2025-08-20
    Product approval · Class 2체외 제인 25-4775 호
  • MFDSIVD reagents for toxin, heavy metal and drugs of abuseRevoked2025-08-20
    Product approval · Class 2체외 제인 25-4772 호
  • MFDSIVD reagents for toxin, heavy metal and drugs of abuseRevoked2025-08-04
    Product approval · Class 2체외 제인 25-4712 호
  • MFDSIVD reagents for toxin, heavy metal and drugs of abuseRevoked2025-08-04
    Product approval · Class 2체외 제인 25-4711 호
  • MFDSIVD reagents for toxin, heavy metal and drugs of abuseRevoked2025-08-04
    Product approval · Class 2체외 제인 25-4710 호
  • MFDSIVD reagents for toxin, heavy metal and drugs of abuseRevoked2025-08-04
    Product approval · Class 2체외 제인 25-4708 호
  • MFDSIVD reagents for toxin, heavy metal and drugs of abuseRevoked2025-08-04
    Product approval · Class 2체외 제인 25-4706 호
  • MFDSIVD reagents for toxin, heavy metal and drugs of abuseRevoked2025-08-04
    Product approval · Class 2체외 제인 25-4705 호
  • MFDSIVD strip for endocrine self testRevoked2024-04-08
    Product approval · Class 2체외 제인 24-372 호
  • MFDSIVD strip for endocrine self testRevoked2024-04-05
    Product approval · Class 2체외 제인 24-371 호
  • MFDSOther reagents, classⅡ, for molecular diagnosticsRevoked2023-11-09
    Product approval · Class 2체외 제인 23-5245 호
  • MFDSIVD reagents for histocompatibility antigen, antibody not for transfusion or transplantation but for specific disease diagnosis, molecular diagnosticsRevoked2023-08-01
    Product approval · Class 2체외 제인 23-4971 호
Show 51 more
  • MFDSIVD reagents for histocompatibility antigen, antibody not for transfusion or transplantation but for specific disease diagnosis, molecular diagnosticsRevoked2023-08-01
    Product approval · Class 2체외 제인 23-4970 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 methodRevoked2023-06-16
    Product approval · Class 3체외 제허 23-676 호
  • MFDSOther reagents, classⅠ, for molecular diagnosticsRevoked2023-04-12
    Product approval · Class 1체외 제신 23-648 호
  • MFDSIVD reagents for pharmacogeneticsRevoked2023-03-14
    Product approval · Class 3체외 제허 23-362 호
  • MFDSOther reagents, classⅠ, for molecular diagnosticsRevoked2023-01-05
    Product approval · Class 1체외 제신 23-20 호
  • MFDSSpecimen transport mediaRevoked2022-11-09
    Product approval · Class 1체외 제신 22-1567 호
  • MFDSIVD reagents for extracting nucleic acidsRevoked2022-10-11
    Product approval · Class 1체외 제신 22-1394 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 diagnosticsRevoked2022-06-28
    Product approval · Class 3체외 제허 22-414 호
  • MFDSSpecimen transport mediaRevoked2021-12-02
    Product approval · Class 1체외 제신 21-1591 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 diagnosticsRevoked2021-03-18
    Product approval · Class 3체외 제허 21-202 호
  • MFDSIVD reagents for cancer related geneRevoked2020-11-11
    Product approval · Class 3체외 제허 20-954 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 diagnosticsRevoked2020-06-22
    Product approval · Class 3체외 제허 20-497 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 diagnosticsRevoked2020-06-15
    Product approval · Class 3체외 제허 20-477 호
  • MFDSGeneral gene amplificator, nucleic acid, without fluorescence meterRevoked2020-05-15
    Product approval · Class 1체외 제신 20-657 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 diagnosticsRevoked2020-05-12
    Product approval · Class 3체외 제허 20-355 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 diagnosticsRevoked2020-03-03
    Product approval · Class 3체외 제허 20-152 호
  • MFDSMolecular diagnostic reagents for congenital or genetic diseaseRevoked2019-10-14
    Product approval · Class 3체외 제허 19-644 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 diagnosticsRevoked2018-03-22
    Product approval · Class 3체외 제허 18-189 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 diagnosticsRevoked2017-01-03
    Product approval · Class 3체외 제허 17-11 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 diagnosticsRevoked2017-01-03
    Product approval · Class 3체외 제허 17-10 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 diagnosticsRevoked2017-01-03
    Product approval · Class 3체외 제허 17-9 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 diagnosticsRevoked2016-12-30
    Product approval · Class 3체외 제허 16-1032 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 diagnosticsRevoked2016-12-30
    Product approval · Class 3체외 제허 16-1031 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 diagnosticsRevoked2016-12-30
    Product approval · Class 3체외 제허 16-1029 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-1005 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-1004 호
  • MFDSMolecular diagnostic reagents for congenital or genetic diseaseRevoked2016-12-22
    Product approval · Class 3체외 제허 16-1003 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-1002 호
  • MFDSIVD reagents for genotyping or patient monitoring of HIV, HBV, HCV, HTLV, molecular diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-1001 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-1000 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-999 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-998 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-997 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-996 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-995 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-994 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-993 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-992 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-991 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 diagnosticsRevoked2016-12-22
    Product approval · Class 3체외 제허 16-990 호
  • MFDSGeneral gene amplificator, nucleic acid, without fluorescence meterRevoked2016-11-03
    Product approval · Class 1체외 제인 16-4841 호
  • MFDSMolecular diagnostic reagents for congenital or genetic diseaseRevoked2016-07-08
    Product approval · Class 3체외 제허 16-491 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 diagnosticsRevoked2016-06-01
    Product approval · Class 3체외 제허 16-395 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 diagnosticsRevoked2016-05-23
    Product approval · Class 3체외 제허 16-379 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 diagnosticsRevoked2014-11-14
    Product approval · Class 3체외 제허 14-2198 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 diagnosticsRevoked2014-11-13
    Product approval · Class 3체외 제허 14-2156 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 diagnosticsRevoked2014-08-29
    Product approval · Class 3체외 제허 14-1581 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 diagnosticsRevoked2014-04-14
    Product approval · Class 3체외 제허 14-868 호
  • MFDSGeneral gene amplificator, nucleic acid, without fluorescence meterRevoked2014-03-21
    Product approval · Class 1체외 제허 14-691 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 diagnosticsRevoked2014-02-14
    Product approval · Class 3체외 제허 14-410 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 diagnosticsRevoked2014-01-16
    Product approval · Class 3체외 제허 14-148 호
Not yet compiled: business overview · R&D. Send us materials and we will add them

Companies approved for the same productsMedical Devices

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

BIONEERCORPORATION8 shared

Bioneer, founded in 1992 and KOSDAQ-listed in 2005, provides gene analysis equipment, molecular diagnostics, and RNAi drug development.

OSANG HEALTHCARE CO.,LTD.8 shared

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

SEEGENE, INC.8 shared

Founded in 2000 and KOSDAQ-listed in 2010, Seegene develops syndromic multiplex PCR molecular diagnostic reagents.

GC Medical Science Corporation7 shared

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

Boditech Med Inc.5 shared

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

Gencurix Inc.5 shared

Founded 2011, KOSDAQ-listed 2020, Gencurix develops liquid-biopsy diagnostics: breast cancer prognosis and lung/colorectal companion tests.

SD BIOSENSOR INC.5 shared

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

CALTH. Inc4 shared

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

Genomictree Inc.4 shared

Cancer molecular diagnostics company behind the EarlyTect-C stool-based colorectal cancer test using the SDC2 methylation biomarker.

Median Diagnostics Inc.4 shared

Founded in 1999 and listed on KONEX in 2017, Median Diagnostics develops and manufactures immunoassay, molecular, and point-of-care in vitro diagnostic kits for animal diseases.

NanoenTek,Inc.4 shared

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

PCL. Inc4 shared

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

Sources and updates

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

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