Sebia’s CAPILLARYS 3 DBS Devices Gets Grant Clearance

Sebia’s CAPILLARYS 3 DBS Devices Gets Grant Clearance

By, Admin 9 April 2024

US FDA grants 510(k) clearance to Sebia’s CAPILLARYS 3 DBS devices

Overview

Sebia, a global specialty diagnostic company, announced that it has received 510(k) clearance from the US Food and Drug Administration (FDA) for CAPILLARYS 3 DBS devices.

Their Solution

  • Our solution is intended for the detection of normal haemoglobins (F and A) and abnormal haemoglobins (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 cyber-secured environment.

Words from Sebia Group

As a global leader for haemoglobinopathy testing, Sebia is expanding its portfolio in the United States with this innovative solution, which can be easily integrated into the laboratory workflow significantly reducing manual intervention while ensuring comprehensive traceability. This will help laboratories to make timely and accurate decisions for newborns” said Arnaud Collin, Sebia Group vice president global regulatory affairs & quality.

About Sebia Group

  • Founded in 1967, Sebia is a world-leading provider of clinical protein electrophoresis equipment and reagents, a technology used for in vitro diagnostic testing. 
  • Its systems analyze proteins in order to screen and monitor various diseases and conditions; primarily oncology (multiple myeloma) and metabolic disorders such as diabetes, also hemoglobinopathy and rare pathologies.

Optimize Your trial insights with Clival Database.

Are you exhausted from the uncertainty of trial insights pricing? Clival Database ensures the clarity in the midst of the global scenario for clinical trials to you.

Clival Database is one of the best databases that offers an outstanding number of clinical trial data in terms of 50,000+ molecules and from primary regulatory markets as well as new entrants like Indian and Chinese markets.

With Clival, you get accurate positioning of historical sales data, patent database, company profiling, safety & efficacy, and prediction of launch of new innovative molecules helping you to align your research and driving down the cost.

To add value, we further break down our analytics for you so that improving your operational effectiveness; optimizing your clinical trials; and offering you accurate and high-quality data at lowest possible prices becomes possible.

Elevate your trial success rate with the cutting-edge insights from Clival database.

Check it out today and make more informed sourcing decisions! Learn More!