Laboratory Overview
Humasis Central R&D Center is making every effort to secure various source
technologies in order to respond to the rapidly changing in vitro diagnostic reagent
development technology.
2020 - NOW
Ministry of Food and Drug Safety Approves Humasis COVID -19/Flu Ag Combo test
Acquired CE certificate for COVID-19 Antigen Test Kit (COVID-19 Ag Home Test)
Acquired CE certificate for COVID-19 Antigen Test Kit (COVID-19 IgG/IgM Test)
2010 - 2019
Acquired permission to produce HUBI TESTO, HUBI-IL6 medical device
Acquired CE certificate for urinalysis (urine chemistry analyzer and reagent)
Acquired CE certificate for Pregnancy Test Kit, Self-testing (Annex 3.6)
2000 - 2009
Established Central R&D Center
Acquired ISO certificate (9001:2000/KS A 9001:2001 DAS Certification)
Acquired ISO 13485:2003 and CE mark
Acquired European CE certificate (Humasis CK-MB, Humasis Myoglobin)
Strengths of R&D Center
01
Outstanding Technologies and Talented Research Personnel
Humasis has key POCT-related original technologies, and its specialized research teams work on continuous R&D to secure diverse original technologies.
02
Development of Various Products
Humasis researches and develops various products to early detection, prevention, and management of various diseases.
The test results are available within 60 minutes.
The products have high sensitivity, specificity, and flexibility for application to various instruments.
03
System and Service Development Competence
Based on its system and service development competence, Humasis develops healthcare solutions for disease management, mobile diagnosis solutions for remote therapy, artificial intelligence, LIS, and HIS.