PR Newswire PharmaOriginal article
Werfen Announces US FDA 510(k) Clearance and CE Mark for Aptiva® Antiphospholipid Syndrome IgA Reagent
RegulatoryapprovedAptiva Antiphospholipid Syndrome IgA ReagentPositive
AI Analysis
Summary
Werfen announced US FDA 510(k) clearance and CE Mark approval for its Aptiva Antiphospholipid Syndrome IgA Reagent, completing the company's APS testing portfolio. The approvals expand global access to comprehensive antiphospholipid syndrome diagnostics.
Outcome Details
US FDA 510(k) clearance and CE Mark received for Aptiva Antiphospholipid Syndrome IgA Reagent
Importance:6/10
Sentiment:
0.70
FDA clearance510(k)CE Markdiagnosticantiphospholipid syndromeregulatory approval
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Published by PR Newswire Pharma on September 23, 2026 12:00 PM