
Immunostics Inc.,
Free shipping on orders over $99 · 30-day returns
MONOCOL/LEX-IM TEST is an FDA 510(k)-cleared medical device (K972457) manufactured by Immunostics Inc.,. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 30, 1997. Regulation: 8.