
Bayer Diagnostics Corp.
Free shipping on orders over $99 · 30-day returns
ADVIA CHEMISTRY ALPHA-1 ANTITRYPSIN ASSAY is an FDA 510(k)-cleared medical device (K031857) manufactured by Bayer Diagnostics Corp.. This device is classified under the Immunology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 2003. Regulation: 8.