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

Celera Diagnostics
Free shipping on orders over $99 · 30-day returns
CYSTIC FIBROSIS GENOTYPING ASSAY, MODEL 6L20-01 is an FDA 510(k)-cleared medical device (K062028) manufactured by Celera 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 6, 2007. Regulation: 8.