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Incstar obtains US approval for complement activation enzyme (CAE) assay:

This article was originally published in Clinica

Executive Summary

Incstar (US) has been granted 510(k) clearance by the US FDA for its first-generation complement activation enzyme assay. The product was launched outside the US in the second quarter of this year. The CAE assay provides general information about the patient's immune system in certain diseases including systemic lupus erythematosus, rheumatic disorders and massive tissue injury.

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