
Biopool Intl., Inc.
Free shipping on orders over $99 · 30-day returns
FETAL D TECTION KIT is an FDA 510(k)-cleared medical device (K980314) manufactured by Biopool Intl., 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 April 7, 1998. Regulation: 8.