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Home Industry News FDA approve Grifols’ BLOODchip product

FDA approve Grifols’ BLOODchip product

19th October 2018

Grifols has received FDA approval for its ID Core XT molecular diagnostic test for in-vitro diagnostic applications, produced by its firm Progenika, and its ID Core Control positive controls and BIDS XT software. The ID Core XT kit is for cancer patients who need more thorough blood typing and patients with warm autoimmune hemolytic anemia, and also patients with ongoing transfusions, including individuals with hemoglobinopathies. It uses polymerase chain reaction technologies to amplify DNA samples, and can be combined with Luminex technology to precisely identify genetic markers that code for red blood cell antigens. BIDS XT is an advanced software that will hold database, help maintain the traceability and transfer data to the LIS.
Carsten Schroeder, commercial diagnostic division president at Grifols said: “We are proud to welcome ID CORE XT to our family of FDA approved blood typing products and services. This test reinforces our commitment to provide high-quality solutions that improve transfusion medicine practices and patient care.”
Dr Peter Marks, director of FDA’s Center for Biologics Evaluation and Research, said: “The approval of the ID CORE XT Test can streamline blood compatibility testing and provides an additional alternative to testing blood with antisera.”

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