The Food and Drug Administration (FDA) has approved the ID CORE XT molecular diagnostic test for in-vitro diagnostic (IVD) use in the United States. The blood group genotyping kit has been CE-IVD marked in Europe since 2014....
Grifols Announces Procleix® Zika Virus Assay Approved by the FDA for Blood Screening on the Procleix® Panther® System
8/14/18: “This approval marks yet another milestone for Grifols Diagnostic Division, and continues to strengthen our leadership position in NAT blood screening safety,” said Carsten Schroeder, President, Grifols Diagnostic Commercial Operations. ”With more assays currently under development, our teams will relentlessly continue to address any threat to the blood supply, and support our mission to improve patients’ well-being and blood safety worldwide.”
6/19/18: "These FDA approvals demonstrate our ongoing commitment to expand Grifols comprehensive Nucleic Acid Testing (NAT) solutions portfolio to help labs administer NAT," said Carsten Schroeder, President, Grifols Diagnostic Division. "The addition of the Procleix Panther system with these assays will allow blood centers to efficiently screen for infectious diseases on one simple, automated platform while adapting to changes in donation volume and regulatory requirements."