Lumipulse G TP-N Immunoreaction Cartridge Set

Lumipulse G TP-N Immunoreaction Cartridge Set is an FDA 510(k)-cleared medical device (K153145) manufactured by Fujirebio Diagnostics,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 July 4, 2016. Regulation: 8.