Healix Assistant
Ask me anything about our products
Quick questions
Powered by Healix AI · Talk to a human

Iris Molecular Diagnostics
Free shipping on orders over $99 · 30-day returns
NUCLEIC ACID DETECTION IMMUNOASSAY (NADIA) PSA ASSAY is an FDA 510(k)-cleared medical device (K101185) manufactured by Iris Molecular Diagnostics. 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 19, 2011. Regulation: 8.