2-reagent Vitamin D assay
Diazyme Laboratories, Inc. announced that the FDA has granted 510(K) clearance to market its two-reagent Vitamin D assay, the only fully automated two-reagent Vitamin D test for use on validated clinical chemistry analysers. Diazyme’s EZ Vitamin D assay is a universal fully automated Vitamin D test that is specifically designed for use on clinical chemistry analysers. This liquid stable, ready-to-use two reagent system measures total 25-hydroxy Vitamin D (25-OH Vitamin D2 + 25-OH Vitamin D3) levels. This assay enables clinical laboratories of almost any size to run Vitamin D test in house without the need for expensive specialized instrumentation. With no sample pre-treatment or pre-dilution steps required, this high-throughput liquid stable assay provides precise test results, is user friendly, cost effective and has excellent correlation to the existing commercial methods.