Myocardial Infarction Self-Testing Kit Receives EU Clearance

China Sky One Medical Inc. has received Conformité Européenne (CE) certification for its Myocardial Infarction and Urine Microalbumin Diagnostic Kits, approving them for sale in the European Union member countries. The AMI diagnostic kit can be used by consumers for the early diagnosis of myocardial infarction. It requires the user to place a blood sample on a marker after which a plus or minus sign will appear, indicating whether the user should seek medical attention. It is based on an assay of heart-type fatty acid binding protein (hFABP), which peaks as early as one hour after myocardial damage occurs, much earlier than the clinically used markers troponin and CKMB. The kit has already been on the market in China since 2007. The Microalbumin Kit is based on an ELISA test showing if microalbuminuria is present, indicating early kidney disease.
Press release: China Sky One Medical Receives CE Mark Approval for Myocardial Infarction and Urine Microalbumin Diagnostic Kits…
Product Information: Diagnostic Kits from China Sky One Medical…