Hemagen Diagnostics' tests for cardiovascular risk cleared:
This article was originally published in Clinica
Hemagen Diagnostics has received FDA 510(k) clearance to market two reagents used to evaluate cardiovascular risk. Both the cholesterol rapid liquid reagent and liquid triglycerides glycerol phosphate oxidase reagent are stable for two years from the date of manufacture when refrigerated. The cholesterol reagent has received certificates of traceability for use with major chemistry analysers according to the standards set by the National Cholesterol Education Programme in the US.