30 June 2020 | News
Clinical Diagnostics, Remote Patient Monitoring Now Possible With Class I IVD Mitra Device
Image credit- prnasia
The Mitra® microsampling device from US company Neoteryx has been registered as a Class I in vitro diagnostic (IVD) medical device with the Therapeutic Goods Administration (TGA) in Australia.
Designed for remote use, Mitra devices enable anyone to collect their own blood at home with a simple finger-stick method.
The Mitra device is based on volumetrically absorptive microsampling (VAMS®) technology, which enables a scientifically precise volume of blood to be collected on its absorbent tip.
Doctors, researchers and labs in Australia can send Mitra devices and Mitra Blood Collection Kits to patients or clinical trial participants who must stay safe at home or who live in remote areas.
A key advantage of Mitra is that no visit to a clinic or phlebotomist for a blood draw is necessary—this easy-to-use device collects a high-quality blood sample for accurate, validated lab testing for clinical diagnostics that inform decisions about medical treatment.
"With the TGA registration, Mitra microsampling devices and Mitra Blood Collection Kits from Neoteryx can be imported into Australia for use in both research and clinical diagnostic applications," said Loc Huynh, MS, RAC, Regulatory Affairs and Quality Director, Neoteryx.