NK Vue® Kit
NK VUE Kit is an NK cell activity test that quantitatively measures IFN-gamma released from activated NK cells with using a small amount of blood (1ml).
NK VUE Kit, a quantitative in vitro diagnostic test,
was approved by the Korean Ministry of Food & Drug Safety (KFDA) in 2012 and certified by
the Ministry of Health & Welfare as a new medical technology in 2014.
NK Vue® Kit Test Method
With NK VUE, NK cells in the blood are artificially activated using a patented NK Cell activator (Promoca), then the amount of Interferon gamma secreted during activation is measured by enzyme-linked immunosorbent assay (ELISA).
Characteristics of NK Vue® Kit
- Oct 2012 Approved by the Korean Ministry of Food & Drug Safety as an IVD device.
- Jun 2014 Certified by the Ministry of Health and Welfare as a new medical technology.
- Apr 2013 ISO 13485 certification
- Aug 2014 CE Mark Registration in Europe
- Dec 2014 ISO 13485 certified in Canada and Health Canada approved
- Jul 2015 LDT Approved in USA
- Jul 2017 NK VUE product approved in Thailand
- Sep 2017 NK VUE product approved and registered for Public Reimbursement in Turkey.
- Jan 2018 NK VUE product approved in Kazakhstan
- Jan 2018 NK VUE product approved in Indonesia
- Mar 2018 NK VUE product approved in Singapore
- Aug 2018 NK VUE product approved in Vietnam