
Beckman Coulter, Inc.
Free shipping on orders over $99 · 30-day returns
ACCESS TOXO IGM II REAGENTS FOR USE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 34470, 34475, AND 34479 is an FDA 510(k)-cleared medical device (K002453) manufactured by Beckman Coulter, Inc.. 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 30, 2000. Regulation: 8.