
Sigma Diagnostics, Inc.
Free shipping on orders over $99 · 30-day returns
SIGMA DIAGNOSTICS INFINITY BUN REAGENT, MODELS 63-25, 63-100P, 63-500P, 63-2000P, 64-20, 64-100P is an FDA 510(k)-cleared medical device (K992800) manufactured by Sigma Diagnostics, 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 September 27, 1999. Regulation: 8.