Beckman Coulter Receives FDA Clearance on Vitamin D Total Assay for Use on Access 2 and UniCel DxI Immunoassay Systems
2015 AACC Annual Meeting Press ProgramBeckman Coulter Diagnostics has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Access 25(OH) Vitamin D Total assay. Offering state-of-the-art performance, the new assay is an important addition to the company’s bone metabolism assay menu and is available for use on its Access 2 and UniCel DxI series of immunoassay systems.