Devyser Diagnostics has received In Vitro Diagnostic Regulation (IVDR) certification for its noninvasive fetal rhesus D (RHD) screening test.
In a statement, the Stockholm-based Devyser noted that the approval granted to its RHD test is the first such approval of a Class D product under the European Union's IVDR regulations; Class D products are considered the highest risk.
The Devyser RHD test is a quantitative polymerase chain reaction CE-IVD test designed for noninvasive screening of fetal RHD status in maternal plasma from the 10th week of gestation. According to the company, the test requires less than an hour of hands-on time and delivers a turnaround time of under five hours.
