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FDA clears Aptiva Connective Tissue Disease Essential reagent

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November 2023—Werfen announced FDA 510(k) clearance of its Aptiva Connective Tissue Disease Essential reagent, to aid in diagnosing connective tissue disease. The Aptiva CTD Essential complements Werfen’s previously cleared Aptiva Celiac Disease reagent.

Aptiva is a fully automated system that uses particle-based multianalyte technology (PMAT), which processes multiple analytes simultaneously from a single patient sample. PMAT enables the Aptiva CTD Essential reagent to deliver up to 600 results per hour. Aptiva will target additional autoimmune disease states and has more than 60 analytes in various stages of advanced development.

Werfen, 800-955-9525

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