De novo classification granted for ADAMTS13 activity test

April 2024—Technoclone and its distributor in the United States, DiaPharma Group, announced that the FDA has granted de novo classification for the Technozym ADAMTS13 Activity ELISA. The assay is intended for the qualitative determination of ADAMTS13 activity in platelet poor human citrated plasma and indicated for use in conjunction with other clinical and laboratory findings as an aid in diagnosing thrombotic thrombocytopenic purpura in adult and pediatric patients being evaluated for thrombotic microangiopathy.

Technoclone, +43 1 863 73-0
DiaPharma, 800-526-5224