BC Week In Review | Jul 5, 2010
Clinical News

EliA ENA assays regulatory update

FDA granted 510(k) clearance to 4 of Phadia's EliA autoimmune antibody assays to help physicians diagnose antiphospholipid syndrome. The assays are designed to detect anti- cardiolipin (aCL) IgG/IgM and anti-B2-glycoprotein 1 (B2-GP1) IgG/IgM, and are...
BC Week In Review | Jul 13, 2009
Clinical News

EliA ENA assays regulatory update

Phadia received CLIA certification from FDA for its EliA extractable nuclear antibody (ENA) assays to support diagnosis of connective tissue disease by detecting antibodies against Sm, U1RNP, RNP70, Ro, La, Scl-70, CENP and Jo-1 antigens....
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