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Axis-Shield anti-CCP Elisa kit wins FDA approval

In vitro diagnostics company Axis-Shield has received the US Food and Drug Administration (FDA) 510(k) approval for its anti-CCP Elisa kit for the diagnosis of rheumatoid arthritis.

The new kit increases the assay range and contains changed components for reduced manufacturing costs and improved margins.

Axis-Shield CEO Ian Gilham said the clearance of their new anti-CCP assay by the FDA will broaden their offering of diagnostics in areas of clinical need, both to the laboratory market and at the point of care.