The high throughput solution for newborn hemoglobin disorders screening.
Sebia receives U.S. FDA Clearance for the CAPILLARYS 3 DBS devices
The next generation instrument for screening hemoglobin disorders in newborns.
Lisses, France, April 5th, 2024 – Sebia, a global specialty diagnostic company providing innovative solutions for screening and diagnostics in oncology, metabolic diseases, genetic disorders and autoimmune diseases, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for CAPILLARYS 3 DBS devices.
Our solution is intended for the detection of normal hemoglobins (F and A) and abnormal hemoglobins (S, C, E, D and Bart’s) in blood from human newborn collected on filter paper. This qualitative analysis is performed by capillary electrophoresis with the CAPILLARYS 3 DBS automated instrument. This offer provides laboratories a gain in operational efficiency with high throughput and a full traceability from DBS card up to the result through a cybersecured environment.
