
Xtrana, Inc.
Free shipping on orders over $99 · 30-day returns
AUTODIMER ASSAY MODEL # 1431 is an FDA 510(k)-cleared medical device (K012755) manufactured by Xtrana, Inc.. This device is classified under the Hematology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 2002. Regulation: 8.