Werfen Receives US FDA 510(K) Clearance for Aptiva® Connective Tissue Disease Essential Reagent
SAN DIEGO, Oct. 16, 2023 /PRNewswire/ -- Werfen today announced 510(k) clearance of Aptiva® Connective Tissue Disease (CTD) Essential reagent by the US Food and Drug Administration (FDA).
- New Reagent Aids in Diagnosis of Connective Tissue Disease in Hard-to-Diagnose Autoimmune Diseases, Reducing Time to Diagnosis and Improving Patient Outcomes
The Aptiva CTD Essential complements Werfen's previously cleared Aptiva Celiac Disease reagent. - In addition to CTD and Celiac Disease assays, Aptiva will target additional autoimmune disease states, and has over 60 analytes in various stages of advanced development.
- "We are excited to bring this latest expansion of the Aptiva reagent menu to the US market, resulting in advanced patient care."
- PMAT enables Aptiva CTD Essential reagent to deliver up to 600 results per hour and allows the laboratory to complete its test volume with minimal hands-on time.