CELLABS GIARDIA CEL I.F. TEST

CELLABS GIARDIA CEL I.F. TEST is an FDA 510(k)-cleared medical device (K912152) manufactured by Celltech Diagnostics , Ltd.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on August 11, 1991. Regulation: 8.