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Werfen Aptiva APS IgA Reagent Cleared by FDA and CE Marked
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Medtech
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United States
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Fusion42 · 24 September 2026 · Fusion42 review
Werfen's Aptiva APS IgA Reagent has received FDA 510(k) clearance and CE marking, completing its antiphospholipid syndrome testing portfolio for all three Ig isotypes on its automated Aptiva platform, enhancing autoimmune diagnostic options.
This Wire brief sits within Fusion42's coverage of Medtech.
◆ ◆ The Wire takeaway
You can now offer full antibody profiling for antiphospholipid syndrome with automated IgA testing included, making your diagnostics more comprehensive and clinically valuable.
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1 source · 24 Sep 2026
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Medtechfda-clearancece-markautoimmune-testingapsdiagnostics