PR Newswire BiotechOriginal 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 FDA 510(k) clearance and CE Mark for its Aptiva Antiphospholipid Syndrome IgA Reagent, expanding its APS testing portfolio and enabling global access to comprehensive APS diagnostic testing.
Outcome Details
US FDA 510(k) clearance and CE Mark received for Aptiva Antiphospholipid Syndrome IgA Reagent
Importance:6/10
Sentiment:
0.80
FDA clearance510(k)CE Markdiagnosticantiphospholipid syndromeregulatory approval
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Published by PR Newswire Biotech on September 23, 2026 12:00 PM