International Organization for Standardization (ISO 13485:2016)
ISO 13485:2016 is an internationally recognized standard that specifies requirements for a quality management system for medical device manufacturers. This certification ensures that the manufacturer can demonstrate its ability to consistently deliver quality medical devices and related services that meet customer requirements and applicable regulatory requirements. It also demonstrates CTK’s proven commitment to quality through an internationally recognized standard.
CE Mark for Medical Devices
Most of CTK’s diagnostic test kits are CE marked. In order for products to be placed on the European market, they must meet the requirements of the relevant product directives. With the CE marking, products may be freely distributed and sold throughout the EU.
CE Certificate for OnSite HIV 1/2 Ab Plus Combo Rapid Test, OnSite HCV Ab Plus Combo Rapid Test, and OnSite HBsAg Combo Rapid Test
OnSite HIV 1/2 Ab Plus Combo Rapid Test, OnSite HCV Ab Plus Combo Rapid Test, and OnSite HBsAg Combo Rapid Test have received CE Mark approval from European regulators. The three test devices are now cleared for commercialization within the European Union (EU) for rapid, point-of-care detection of HIV, HCV and HBsAg.