Information
132 Anyangcheondong-ro, Dongan-gu, Anyang, Gyeonggi-do, South Korea
+82 31-460-0401
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Overview
- Summary
- OSANG Healthcare is a specialized in-vitro diagnostic medical device company dedicated to the development of blood diagnostic biosensors. The company possesses advanced biotech capabilities across biochemical, immunoassay, and molecular diagnostics, including biosensors for blood glucose, HbA1c, and cholesterol measurement. It aims to achieve 'Technology for Everyone' by making medical equipment as accessible as home appliances, enabling simple measurement of all diseases. The company exports its diagnostic solutions to over 110 countries worldwide, solidifying its position in the global healthcare market. Its goal is to become a leading enterprise in diagnostic biotechnology through research and development of diagnostic sensors for heart disease, cancer, and remote diagnostic systems.OSANG Healthcare is a specialized in-vitro diagnostic medical device company dedicated to the development of blood diagnostic biosensors. The company possesses advanced biotech capabilities across biochemical, immunoassay, and molecular diagnostics, including biosensors for blood glucose, HbA1c, and cholesterol measurement. It aims to achieve 'Technology for Everyone' by making medical equipment as accessible as home appliances, enabling simple measurement of all diseases. The company exports its diagnostic solutions to over 110 countries worldwide, solidifying its position in the global healthcare market. Its goal is to become a leading enterprise in diagnostic biotechnology through research and development of diagnostic sensors for heart disease, cancer, and remote diagnostic systems.
- Key Products/Technologies
- Biochemical Diagnostic Product Line: This category includes blood glucose measuring biosensors (GluNEO, GluNEO H, OKRA Pro, Oh'Care Lite, GlucoLab), HbA1c measuring biosensors (CLOVER A1c Plus, CLOVER A1c Expert, CLOVER A1c Self), and cholesterol measuring biosensors (LipidPro Meter, LipidPro HDL-Cholesterol Strip). GluNEO H complies with international quality standards ISO 15197:2013, capable of measuring capillary and venous blood, and features hematocrit compensation technology for enhanced accuracy. CLOVER A1c Plus offers a measurement range of NGSP 4-14% and IFCC 20-130 mmol/mol, with results within 5 minutes, utilizing a boronate affinity method. The LipidPro Meter can measure four types of cholesterol: total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL).Biochemical Diagnostic Product Line: This category includes blood glucose measuring biosensors (GluNEO, GluNEO H, OKRA Pro, Oh'Care Lite, GlucoLab), HbA1c measuring biosensors (CLOVER A1c Plus, CLOVER A1c Expert, CLOVER A1c Self), and cholesterol measuring biosensors (LipidPro Meter, LipidPro HDL-Cholesterol Strip). GluNEO H complies with international quality standards ISO 15197:2013, capable of measuring capillary and venous blood, and features hematocrit compensation technology for enhanced accuracy. CLOVER A1c Plus offers a measurement range of NGSP 4-14% and IFCC 20-130 mmol/mol, with results within 5 minutes, utilizing a boronate affinity method. The LipidPro Meter can measure four types of cholesterol: total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL), and low-density lipoprotein (LDL).
- Immunoassay Diagnostic Product Line: This includes antigen/antibody diagnostic kits and devices such as the COVID-19 Antigen Self Test, COVID/Flu Combo Test, and GeneFinder COVID-19/Flu Antigen Professional Test. The COVID/Flu Combo Test is the world's first product to receive FDA 510(k) clearance for simultaneous detection of COVID-19 and Influenza A&B. The company also possesses the 'SelexOn' immunoassay diagnostic product, co-developed with the Korea Research Institute of Bioscience and Biotechnology.Immunoassay Diagnostic Product Line: This includes antigen/antibody diagnostic kits and devices such as the COVID-19 Antigen Self Test, COVID/Flu Combo Test, and GeneFinder COVID-19/Flu Antigen Professional Test. The COVID/Flu Combo Test is the world's first product to receive FDA 510(k) clearance for simultaneous detection of COVID-19 and Influenza A&B. The company also possesses the 'SelexOn' immunoassay diagnostic product, co-developed with the Korea Research Institute of Bioscience and Biotechnology.
- Molecular Diagnostics Product Line: This encompasses GeneFinder™ PCR test kits, including GeneFinder™ COVID-19/Flu A&B RealAmp Kit, GeneFinder™ JEV/WNV RealAmp Kit, GeneFinder™ HLA RealAmp Kit series, GeneFinder™ STD II/III Multiplex Real-time PCR Kit, and GeneFinder™ Malaria RealAmp Kit. This technology enables rapid and accurate identification of infectious diseases by efficiently extracting and amplifying DNA/RNA.Molecular Diagnostics Product Line: This encompasses GeneFinder™ PCR test kits, including GeneFinder™ COVID-19/Flu A&B RealAmp Kit, GeneFinder™ JEV/WNV RealAmp Kit, GeneFinder™ HLA RealAmp Kit series, GeneFinder™ STD II/III Multiplex Real-time PCR Kit, and GeneFinder™ Malaria RealAmp Kit. This technology enables rapid and accurate identification of infectious diseases by efficiently extracting and amplifying DNA/RNA.
- Research and Development Technologies: The company holds world-class technological capabilities in blood glucose, HbA1c, and cholesterol measuring biosensors. It possesses expertise in developing diagnostic sensors for heart disease, cancer, and remote diagnostic systems. OSANG Healthcare aims to enter the next-generation diagnostic market through the development of Continuous Glucose Monitoring (CGM) systems.Research and Development Technologies: The company holds world-class technological capabilities in blood glucose, HbA1c, and cholesterol measuring biosensors. It possesses expertise in developing diagnostic sensors for heart disease, cancer, and remote diagnostic systems. OSANG Healthcare aims to enter the next-generation diagnostic market through the development of Continuous Glucose Monitoring (CGM) systems.
- Core Advantages
- Over 25 Years of Experience and Accumulated Technology: Established in 1996, the company has dedicated itself to developing blood diagnostic biosensors, accumulating over 20 years of technology and know-how. It has expanded its business from biochemical diagnostics to immunoassay and molecular diagnostics, securing diverse diagnostic technologies.Over 25 Years of Experience and Accumulated Technology: Established in 1996, the company has dedicated itself to developing blood diagnostic biosensors, accumulating over 20 years of technology and know-how. It has expanded its business from biochemical diagnostics to immunoassay and molecular diagnostics, securing diverse diagnostic technologies.
- Extensive Global Distribution Network: The company has built a robust global distribution network, exporting products to over 110 countries worldwide. It has experience in exporting to major markets such as the US, Brazil, UK, and India, and is actively pursuing localization strategies.Extensive Global Distribution Network: The company has built a robust global distribution network, exporting products to over 110 countries worldwide. It has experience in exporting to major markets such as the US, Brazil, UK, and India, and is actively pursuing localization strategies.
- International Quality Certifications and Regulatory Approvals: OSANG Healthcare has obtained numerous international quality certifications and regulatory approvals, including US FDA EUA, FDA 510(k) clearance, European CE IVDR, ISO 9001, ISO 13485, MDSAP, and KGMP. Notably, it was the first Korean company to receive US FDA approval for personal blood glucose meters.International Quality Certifications and Regulatory Approvals: OSANG Healthcare has obtained numerous international quality certifications and regulatory approvals, including US FDA EUA, FDA 510(k) clearance, European CE IVDR, ISO 9001, ISO 13485, MDSAP, and KGMP. Notably, it was the first Korean company to receive US FDA approval for personal blood glucose meters.
- Comprehensive In-Vitro Diagnostic (IVD) Technology Portfolio: The company has established a broad portfolio of diagnostic solutions spanning biochemical, immunoassay, and molecular diagnostics. It possesses the technological capability to address various medical needs, from chronic disease management to infectious disease diagnosis.Comprehensive In-Vitro Diagnostic (IVD) Technology Portfolio: The company has established a broad portfolio of diagnostic solutions spanning biochemical, immunoassay, and molecular diagnostics. It possesses the technological capability to address various medical needs, from chronic disease management to infectious disease diagnosis.
- POCT (Point-of-Care Testing) Solution Development and User Convenience: The company excels in developing compact point-of-care diagnostic devices suitable for hospitals, clinics, public health centers, and home use. Products like GluNEO H feature intuitive color indicators, large LCD screens, and test strip ejection buttons, maximizing user convenience.POCT (Point-of-Care Testing) Solution Development and User Convenience: The company excels in developing compact point-of-care diagnostic devices suitable for hospitals, clinics, public health centers, and home use. Products like GluNEO H feature intuitive color indicators, large LCD screens, and test strip ejection buttons, maximizing user convenience.
- Continuous R&D Investment and New Growth Engine Securing: OSANG Healthcare is actively pursuing the development of Continuous Glucose Monitoring (CGM) systems as its next growth engine, making strategic investments to lead future markets. The company continuously advances its technologies in point-of-care, molecular, and in-vitro diagnostics through national R&D projects.Continuous R&D Investment and New Growth Engine Securing: OSANG Healthcare is actively pursuing the development of Continuous Glucose Monitoring (CGM) systems as its next growth engine, making strategic investments to lead future markets. The company continuously advances its technologies in point-of-care, molecular, and in-vitro diagnostics through national R&D projects.
- Target Industries
- Medical and Healthcare IndustryMedical and Healthcare Industry
- In-Vitro Diagnostics (IVD) MarketIn-Vitro Diagnostics (IVD) Market
- Hospitals and Clinical LaboratoriesHospitals and Clinical Laboratories
- Point-of-Care Testing (POCT) settings such as clinics, public health centers, and small hospitalsPoint-of-Care Testing (POCT) settings such as clinics, public health centers, and small hospitals
- Home self-testing marketHome self-testing market
- Chronic disease management (diabetes, hyperlipidemia, etc.)Chronic disease management (diabetes, hyperlipidemia, etc.)
- Major Markets
- India, Philippines, Pakistan, Malaysia, VietnamIndia, Philippines, Pakistan, Malaysia, Vietnam
- United KingdomUnited Kingdom
- United StatesUnited States
- BrazilBrazil
- Certifications/Patents
- US FDA EUA (Emergency Use Authorization): Obtained emergency use authorization for SARS-CoV-2 test kits and COVID-19/Flu Combo Test.US FDA EUA (Emergency Use Authorization): Obtained emergency use authorization for SARS-CoV-2 test kits and COVID-19/Flu Combo Test.
- US FDA 510(k) clearance: Obtained clearance for the COVID-19/Flu Combo Test.US FDA 510(k) clearance: Obtained clearance for the COVID-19/Flu Combo Test.
- European CE IVDR (In Vitro Diagnostic Regulation): Obtained certification for personal blood glucose meters.European CE IVDR (In Vitro Diagnostic Regulation): Obtained certification for personal blood glucose meters.
- ISO 9001: International standard certification for quality management systems.ISO 9001: International standard certification for quality management systems.
- ISO 13485: International standard certification for medical device quality management systems.ISO 13485: International standard certification for medical device quality management systems.
- MDSAP (Medical Device Single Audit Program): Certification for the Medical Device Single Audit Program.MDSAP (Medical Device Single Audit Program): Certification for the Medical Device Single Audit Program.
- KGMP (Korea Good Manufacturing Practice): Certification for Korean Good Manufacturing Practice.KGMP (Korea Good Manufacturing Practice): Certification for Korean Good Manufacturing Practice.
- Technological Competence: Over 20 years of accumulated technology and know-how in blood glucose biosensors, capability for both capillary and venous blood measurement, hematocrit compensation technology, enzyme-based HbA1c measurement technology, spectrophotometry, boronate affinity method, and more.Technological Competence: Over 20 years of accumulated technology and know-how in blood glucose biosensors, capability for both capillary and venous blood measurement, hematocrit compensation technology, enzyme-based HbA1c measurement technology, spectrophotometry, boronate affinity method, and more.
Introduction
Location
132 Anyangcheondong-ro, Dongan-gu, Anyang, Gyeonggi-do, South Korea
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