The US FDA grants 510(k) Clearance to Werfen’s Aptiva Antiphospholipid Syndrome (APS) Reagents
Shots:
- The US FDA has granted 510(k) Clearance for Aptiva’s APS IgG & APS IgM reagents, expanding its portfolio from Celiac Diseases & CTD essential reagents to 18 FDA-cleared analytes
- The APS reagents semi-quantitatively detect anti-cardiolipin (aCL), plus anti-β2 glycoprotein 1 (aβ2GP1) IgG & IgM in serum levels, aiding in diagnoses of 1° & 2° APS alongside other laboratory & clinical findings
- Aptiva is a fully automated multi-analyte system that enables high volumes of lab testing through its PMAT tech. to deliver ~960 result in 8hrs. for APS testing. Werfen will expand the Aptiva portfolio to additional autoimmune diseases with 60+ analytes in development
Ref: Prnewswire | Image: Werfen
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A passionate content writer with expertise in delivering high-quality and engaging content, Dipanshu is a keen reader and a versatile writer. Dipanshu dedicatedly covers news ranging from biopharma, life sciences, biotech, and MedTech to diagnostics and animal health companies, FDA, EMA, and biosimilar approvals. He can be contacted at connect@pharmashots.com
