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Medical DevicesKOSDAQ 214610117 approvals

RollingStone Co., Ltd.

Official website

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

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Business overview

Source: DART corporate disclosure

Founded in 2009 and listed on KOSDAQ in 2020, RollingStone is an in-vitro diagnostics company specializing in LabChip-based molecular diagnostics. It offers the VERI-Q PREP M16 gene extraction device, the VERI-Q PCR 316 LabChip-based real-time PCR device with dedicated reagents and a saliva collection kit, and the VERI-Q Multi/VERI-Q Life multi-analyte meters, alongside a Ministry of Food and Drug Safety-approved malaria molecular diagnostic kit and diagnostic kits for respiratory disease, zoonotic infections, animal disease, and foodborne pathogens. The VERI-Q PREP M16 weighs 12kg versus competitors' 20kg and extracts 16 samples within 30 minutes; the VERI-Q PCR 316 weighs 4.7kg versus competitors' 20kg or more, completes 30 cycles within 10 minutes, and detects 16 samples simultaneously on one LabChip; and in January 2024 the company received New Excellent Technology (NET) certification from the Ministry of Agriculture, Food and Rural Affairs for its A1-contamination detection technology for A2 milk.

Products & technology

  • VERI-Q PREP M16Compact rapid pathogen gene extraction device
  • VERI-Q PCR 316LabChip-based real-time PCR device for quantitative pathogen diagnosis
  • VERI-Q PREP reagentDedicated nucleic acid extraction reagent for VERI-Q PREP M16
  • VERI-Q Saliva Collection KitSaliva sample collection kit
  • VERI-Q PCR reagentDedicated Taqman probe-based PCR reagent for VERI-Q PCR 316/204
  • Malaria molecular diagnostic kitMolecular diagnostic test for mosquito-borne malaria infection
  • VERI-Q Multi / VERI-Q LifePOCT device for combined cholesterol, blood glucose, and hemoglobin measurement

Regulatory approvals

data.go.kr

117 Korean MFDS device approvals · 2010–2026

  • MFDSIVD reagents for extracting nucleic acids2026-07-16
    Product approval · Class 1체외 제신 26-887 호
  • MFDSExtractor, nucleic acid2026-07-10
    Product approval · Class 1체외 제신 26-845 호
  • MFDSUltrasound system, imaging, diagnostic, mobile2026-01-02
    Product approval · Class 2제인 26-4000 호
  • MFDSExtractor, nucleic acidRevoked2023-12-15
    Product approval · Class 1체외 제신 23-1774 호
  • MFDSIVD strip for self test2022-12-16
    Product approval · Class 2체외 제허 22-870 호
  • MFDSIVD analyzer for self test2022-12-16
    Product approval · Class 2체외 제허 22-869 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 diagnosticsRevoked2022-09-20
    Product approval · Class 3체외 제허 22-627 호
  • MFDSIVD reagents for extracting nucleic acidsRevoked2022-08-29
    Product approval · Class 1체외 제신 22-1205 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 diagnosticsRevoked2022-04-13
    Product approval · Class 3체외 제허 22-247 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 methodRevoked2022-04-08
    Product approval · Class 3체외 제허 22-237 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 methodRevoked2022-03-24
    Product approval · Class 3체외 제허 22-206 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 diagnosticsRevoked2022-03-03
    Product approval · Class 3체외 제허 22-142 호
Show 68 more
  • 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 diagnosticsRevoked2022-03-03
    Product approval · Class 3체외 제허 22-141 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 diagnosticsRevoked2021-10-20
    Product approval · Class 3체외 제허 21-851 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 methodRevoked2021-09-29
    Product approval · Class 3체외 제허 21-804 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 diagnosticsRevoked2021-09-06
    Product approval · Class 3체외 제허 21-743 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 methodRevoked2021-08-26
    Product approval · Class 3체외 제허 21-723 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 methodRevoked2021-08-20
    Product approval · Class 3체외 제허 21-702 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 methodRevoked2021-08-13
    Product approval · Class 3체외 제허 21-692 호
  • MFDSImmunoabsorbance analyzerRevoked2021-08-10
    Product approval · Class 1체외 제신 21-1092 호
  • MFDSSpecimen transport mediaRevoked2021-06-01
    Product approval · Class 1체외 제신 21-798 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 methodRevoked2021-02-10
    Product approval · Class 3체외 제허 21-107 호
  • MFDSTool for specimensRevoked2021-01-11
    Product approval · Class 1수신 21-28 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 methodRevoked2020-12-01
    Product approval · Class 3체외 제허 20-1019 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 diagnosticsRevoked2020-08-10
    Product approval · Class 3체외 제허 20-637 호
  • MFDSGeneral calibrators, controls or standards, classⅡ, for clinical chemistryRevoked2020-08-10
    Product approval · Class 2체외 제인 20-4721 호
  • MFDSGeneral calibrators, controls or standards, classⅡ, for clinical chemistryRevoked2020-08-10
    Product approval · Class 2체외 제인 20-4720 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 methodRevoked2020-07-23
    Product approval · Class 3체외 제허 20-600 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 diagnosticsRevoked2020-05-11
    Product approval · Class 3체외 제허 20-352 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 diagnosticsRevoked2020-03-26
    Product approval · Class 3체외 제허 20-221 호
  • MFDSIVD reagents for extracting nucleic acidsRevoked2020-03-04
    Product approval · Class 1체외 제신 20-283 호
  • MFDSIVD reagents for extracting nucleic acidsRevoked2020-02-28
    Product approval · Class 1체외 제신 20-247 호
  • MFDSCapillary blood collection tube2020-01-13
    Product approval · Class 1제신 20-54 호
  • MFDSHemoglobin analyzer2020-01-13
    Product approval · Class 1체외 제신 20-56 호
  • MFDSHemoglobin analyzer2019-11-28
    Product approval · Class 1체외 제신 19-1561 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 diagnosticsRevoked2019-09-19
    Product approval · Class 3체외 제허 19-601 호
  • MFDSIVD reagents for diagnosis of HIV, HBV, HCV, HTLV, molecular diagnosticsRevoked2019-09-19
    Product approval · Class 4체외 제허 19-600 호
  • MFDSClinical IVD strip for protein/lipid stripRevoked2019-06-18
    Product approval · Class 2체외 제인 19-4480 호
  • MFDSClinical IVD strip for protein/lipid stripRevoked2019-06-18
    Product approval · Class 2체외 제인 19-4482 호
  • MFDSCholesterol analyzer, laboratory2019-06-14
    Product approval · Class 1체외 제신 19-786 호
  • MFDSIVD reagents for total Hb test2019-06-04
    Product approval · Class 2체외 제인 19-4450 호
  • MFDSHemoglobin analyzerRevoked2019-05-14
    Product approval · Class 1체외 제신 19-614 호
  • MFDSIVD reagents for total Hb testRevoked2019-05-14
    Product approval · Class 2체외 제인 19-4386 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 diagnosticsRevoked2019-04-08
    Product approval · Class 3체외 제허 19-211 호
  • MFDSClinical IVD strip for protein/lipid stripRevoked2019-03-19
    Product approval · Class 2체외 제인 19-4195 호
  • MFDSClinical IVD strip for protein/lipid stripRevoked2019-03-19
    Product approval · Class 2체외 제인 19-4196 호
  • MFDSClinical IVD strip for protein/lipid stripRevoked2019-03-19
    Product approval · Class 2체외 제인 19-4197 호
  • MFDSClinical IVD strip for protein/lipid stripRevoked2019-03-19
    Product approval · Class 2체외 제인 19-4198 호
  • MFDSClinical IVD strip for protein/lipid stripRevoked2019-03-19
    Product approval · Class 2체외 제인 19-4200 호
  • MFDSClinical IVD strip for glucose stripRevoked2019-03-19
    Product approval · Class 2체외 제인 19-4202 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 diagnosticsRevoked2019-01-23
    Product approval · Class 3체외 제허 19-62 호
  • MFDSCholesterol analyzer, laboratory2018-11-22
    Product approval · Class 1체외 제신 18-1555 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 diagnosticsRevoked2018-11-05
    Product approval · Class 3체외 제허 18-720 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 diagnosticsRevoked2018-10-24
    Product approval · Class 3체외 제허 18-700 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 diagnosticsRevoked2018-10-18
    Product approval · Class 3체외 제허 18-693 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 diagnosticsRevoked2018-10-18
    Product approval · Class 3체외 제허 18-692 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 diagnosticsRevoked2018-10-18
    Product approval · Class 3체외 제허 18-691 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 diagnosticsRevoked2018-10-18
    Product approval · Class 3체외 제허 18-690 호
  • MFDSCholesterol analyzer, laboratoryRevoked2018-09-18
    Product approval · Class 1체외 제신 18-1241 호
  • MFDSIVD reagents for general immune testRevoked2018-09-11
    Product approval · Class 2체외 제인 18-4739 호
  • MFDSIVD strip for protein/lipid self testRevoked2018-09-11
    Product approval · Class 2체외 제인 18-4738 호
  • MFDSIVD reagents for general immune testRevoked2018-09-11
    Product approval · Class 2체외 제인 18-4737 호
  • MFDSIVD reagents for general immune testRevoked2018-09-11
    Product approval · Class 2체외 제인 18-4736 호
  • MFDSIVD strip for protein/lipid self testRevoked2018-09-11
    Product approval · Class 2체외 제인 18-4735 호
  • MFDSIVD strip for protein/lipid self testRevoked2018-09-11
    Product approval · Class 2체외 제인 18-4734 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 diagnosticsRevoked2018-09-06
    Product approval · Class 3체외 제허 18-616 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 diagnosticsRevoked2018-09-06
    Product approval · Class 3체외 제허 18-615 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 diagnosticsRevoked2018-09-06
    Product approval · Class 3체외 제허 18-614 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 diagnosticsRevoked2018-09-05
    Product approval · Class 3체외 제허 18-608 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 diagnosticsRevoked2018-08-28
    Product approval · Class 3체외 제허 18-592 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 diagnosticsRevoked2018-08-07
    Product approval · Class 3체외 제허 18-561 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 diagnosticsRevoked2018-08-07
    Product approval · Class 3체외 제허 18-560 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 diagnosticsRevoked2018-08-07
    Product approval · Class 3체외 제허 18-559 호
  • MFDSCapillary blood collection tube2018-08-03
    Product approval · Class 1수신 18-1671 호
  • MFDSOther instruments or devices, classⅡ, for other clinical chemistryRevoked2018-07-24
    Product approval · Class 2체외 제허 18-518 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 diagnostics2018-06-22
    Product approval · Class 3체외 제허 18-446 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 diagnosticsRevoked2018-06-07
    Product approval · Class 3체외 제허 18-400 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 diagnosticsRevoked2018-06-07
    Product approval · Class 3체외 제허 18-401 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 diagnostics2018-04-09
    Product approval · Class 3체외 제허 18-241 호
  • MFDSBlood glucose meter for self testRevoked2017-07-19
    Product approval · Class 3체외 제허 17-528 호

Showing the 80 most recent of 117 records.

R&D and key agreements

Source: DART corporate disclosure

체외진단 원천기술 기반 고성능 신기술·신제품 개발 · 연구개발 진행중 · R&D institute developing higher-performance and new in-vitro diagnostic products based on core proprietary technology

A2 우유 A1 혼입 신속검출기술 · 농림식품신기술(NET) 인증(2024.01) · Real-time nucleic acid amplification technology to distinguish A1/A2 milk; joint gene-screening project with domestic dairy companies

Not yet compiled: business overview. 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.

GC Medical Science Corporation16 shared

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

OSANG HEALTHCARE CO.,LTD.16 shared

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

SD BIOSENSOR INC.15 shared

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

Boditech Med Inc.11 shared

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

HUMASIS CO., LTD.8 shared

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

i-SENS, Inc.8 shared

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

Sugentech, Inc.8 shared

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

BIONEERCORPORATION7 shared

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

CALTH. Inc7 shared

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

NanoenTek,Inc.7 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. Inc7 shared

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

Precision Biosensor Inc.7 shared

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

Sources and updates

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

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