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FDA clears Hemagen's clinical chemistry reagents:

This article was originally published in Clinica

Executive Summary

Hemagen Diagnostics has received US FDA 510(k) clearance to market four of its clinical chemistry reagents - total protein, albumin, calcium and GGT (gamma-glutamyl transferase)- may be use on Roche Diagnostics' Cobas Mira analyser. Waltham, Massachusetts-based Hemagen announced last month that it had entered into a long-term agreement to provide reagents and diagnostic kits manufactured by its Raichem division to Roche Diagnostics (see Clinica No 894, p 10). Hemagen said the newly cleared reagents marked the first of a number of clearances under the agreement and that it was working on further 510 (k) submissions for other products.

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