Biosite seeks 510(k) for Triage blood test:
This article was originally published in Clinica
Biosite has submitted a 510(k) filing in the US for its Triage point-of-care test panel for myocardial infarction. The panel measures whole-blood CK-MB, myoglobin and troponin-I. It runs on an automated instrument, the Triage Carelink, based on a hand-held fluorescence meter. Assay of the three markers gives more accurate diagnostic of MI than the usual procedure of a CK-MB test followed by an electrocardiogram, says Biosite.
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