Sebia Receives U.S. FDA Clearance for the CAPILLARYS 3 DBS devices
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.
- 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.
- 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 cyber-secured environment.
- This will help laboratories to make timely and accurate decisions for newborns” said Arnaud Collin, Sebia Group Vice President Global Regulatory Affairs & Quality.