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Inverness Medical Professional Diagnostics
Free shipping on orders over $99 · 30-day returns
MODIFICATION TO: BINAX NOW LEGIONELLA URINARY ANTIGEN TEST, #852-000,852-012 is an FDA 510(k)-cleared medical device (K070522) manufactured by Inverness Medical Professional Diagnostics. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on March 14, 2007. Regulation: 8.