Diazyme Laboratories has received a 510(k) clearance from the FDA to market its Cystatin C Assay Kit for verifying Cystatin C in serum and plasma samples for the early detection of chronic kidney disease. The Cystatin assay is highly accurate and precise and offers an extended reportable range of 0.47 to over 8 mg/L, reducing the need for repeating tests on elevated samples.