TECHNOCLONE RECEIVES US FDA MARKETING AUTHORIZATION FOR THE FIRST ADAMTS13 ACTIVITY DIAGNOSTIC TEST
WEST CHESTER, Ohio, March 5, 2024 /PRNewswire/ -- Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH, world-leading producer of diagnostic tests, equipment, and research products in the field of blood clotting and its exclusive distributor in the USA, DiaPharma Group, Inc., are pleased to announce that the US Food and Drug Administration (FDA) granted De Novo marketing authorization for Technozym ADAMTS13 Activity ELISA.
- WEST CHESTER, Ohio, March 5, 2024 /PRNewswire/ -- Technoclone Herstellung von Diagnostika und Arzneimitteln GmbH, world-leading producer of diagnostic tests, equipment, and research products in the field of blood clotting and its exclusive distributor in the USA, DiaPharma Group, Inc., are pleased to announce that the US Food and Drug Administration (FDA) granted De Novo marketing authorization for Technozym ADAMTS13 Activity ELISA.
- This is the first ADAMTS13 activity test authorized by the FDA.
- The Technozym ADAMTS13 Activity assay is an enzyme-linked immunosorbent assay (ELISA) intended for the qualitative determination of ADAMTS13 activity in platelet poor human citrated plasma.
- "In line with our commitment to provide ADAMTS13 diagnostics globally, we are excited about this milestone, having the first ADAMTS13 activity test granted with marketing authorization by the FDA", says Nikolaus Binder, MD, PhD, CSO of Technoclone.