Diagnostic solutions provider Devyser has launched its first IVDR-certified product. Devyser Compact is a rapid genetic test for prenatal chromosome testing and is approved under the new more comprehensive regulation that came in May of 2022.
“We’re proud to announce the launch of our first IVDR product on the market. The launch is proof of our hard work to transition to IVDR, and our long-term commitment to quality and patient safety. To our customers it’s a reassurance that we will continue to provide safe and reliable products,” says Theis Kipling, CCO, Devyser.
The original rapid test product was first launched in 2006.
Devyser Compact prenatal chromosome test provides efficient and sensitive detection of chromosomal abnormalities. In addition to detecting the most common syndromes, the test includes patented technology for reliable diagnosis of Turner syndrome. The new version offers laboratories a safe and easy transition to IVDR. The Devyser test kit—with a single tube solution—is easy to use which minimizes hands-on time, analysis time, and the risk of sample mix up.
Devyser Compact is available in all native English-speaking countries. The certification was issued by the notified body TÜV SÜD in August 2022 and covers Devyser Compact and Devyser´s quality management system.
