PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device

PANTEX SALIVARY DIRECT TESTOSTERONE EIA KIT, Pantex Sample Collection Device is an FDA 510(k)-cleared medical device (K133303) manufactured by Bio-Analysis, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 18, 2014. Regulation: 8.