Diazyme Laboratories, a cGMP and ISO 13485-certified medical device manufacturer located in Poway, California recently announced that the U.S. Food and Drug Administration (FDA) has granted 510(K) clearance to market its EZ Vitamin D assay for Clinical Chemistry Analyzers. EZ Vitamin D assay is a universal fully automated Vitamin D test that is specifically designed for use on clinical chemistry analyzers. This liquid stable, ready-to-use two reagent system measures total 25-hydroxy Vitamin D (25-OH Vitamin D2 + 25-OH Vitamin D3) levels. Measurement of 25-hydroxyvitamin D (25-OH-D) is for assessment of vitamin D sufficiency.
Diazyme's Vitamin D assay kit is intended to be used for the quantitative determination of 25-(OH) D levels in serum or plasma, on automated chemistry analyzers, and for the assessment of Vitamin D sufficiency. This kit contains 1 sample diluent and 3 liquid stable reagents and calibrator set.
According to Dr. Chong Yuan, Managing Director of Diazyme Laboratories, "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."
Directly traceable to NIST SRM-972 standards, this assay also features:
- Liquid stable format
- Kit (80 tests)
- 15-19 minutes to first result
- No off-line sample pretreatment needed
- Multiple instrument options
Chemistry analyzers for Diazyme's 25-OH Vitamin D Assay for clinical chemistry assay include Siemens' Dimension Vista, Roche's Cobas Integra 400/800, Cobas Mira and Modular P, Alfa Wassermann's ACE ALERA, Horiba's Pentra 400 and ThermoFisher's Konelab 30 and Indiko Plus. Clinical laboratories and other healthcare settings can purchase this assay at a better price from a professional lab equipment supplier.