In-vitro Diagnostic Medical Devices

https://korean-electronics.com//inquiry[INQ. NO. 1704E20] NanoEnTek has developed key technology of nano scale Bio-MEMS that organizationally combined microelectromechanical system (MEMS) and biotechnology, which is called the technology of the 21st century.
Based on this high technology, NanoEnTek is expanding its business to life science experiment equipment, in-vitro diagnostic medical devices and related solution development.
There are about 100 patents of nano convergence technology that the company has applied for and registered. In particular, one of the company’s key platforms is “lab-on-a-chip,” which is a next-generation technology that will contribute to medicine and life science fields.
NanoEnTek released the world’s fi rst compact automatic cell analyzer named Countess. In 2009, it sold the patented exclusive license of its gene delivery system, MicroPorator, to a global company for US$13 million. It will advance its global targets through the world’s fi rst bench-top residual white blood cell counter ADAM-rWBC, point-of-care diagnostic devices FREND PSA Plus, TSH, Free T4, and Testosterone FDA 510(k) cleared in the United States.
Through active investment, NanoEnTek is now expanding its in-vitro diagnostic business with its existing life science business. In January 2016, it merged with Bio Focus which is a point-of-care diagnostic devices company based on rapid kit. Together, they have reinforced biology capability and presented customized products for each country thanks to diversifi cation of its platform.

 

Representative Products for POCT (Point-of-Care- Testing) by NanoEnTek

The FREND system is a small, rapid and near-patient in-vitro diagnostic for quantitative measurement of biomarkers in patient samples. This quantitative immunoassay analyzer speedily delivers results within three minutes after a simple three-step process.
And it is easy to use with touchscreen GUI, which allows saving in USB drive. It is accurate by performing bett er than other diagnostic devices. It is also compact with 3kg weight, requiring no restriction for installation space. What’s more, it is FDA 510K certified.
BioTracer is a rapid diagnostic test that is quick and easy to perform for qualitative measurement. It is capable of manufacturing gold-conjugates, recombinant antigen and antibodies. It markets products that satisfy WHO standards (Malaria, HIV), U.S. FDA(hCG) and the CE mark. With accumulated know-how on manufacturing rapid tests, its sales now extend to over 40 countries. ADAM-rWBC is an analyzing device that counts the number of residual leukocytes in a blood component for transfusion.
ADAMII-CD34 is a bench-top fl uorescent CD34 counting analyzer that can be used in hospitals and research laboratories. It has 4-channel light sources and performs assays for CD34+ cells as well as cell viability (CD34, total cell) simultaneously.
BUDDI is an image analyzer that evaluates the line signal intensities of analyte and control line on the test device. It has smart connectivity (EMR/LIS & Wi-Fi) with easy and fast test procedures. It also has a user-friendly touchscreen interface.

 

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