By Editor , 23 September 2026 Werfen Wins FDA Clearance, CE Mark for Aptiva APS IgA Assay San Diego – September 23, 2026 -- Werfen has secured U.S. FDA 510(k) clearance and a CE Mark under the EU's IVDR for its Aptiva Antiphospholipid Syndrome (APS) IgA Reagent, completing a three-isotype APS testing portfolio on its Aptiva platform.
