MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL

MYCOPLASMA PNEUMONIAE ANTIGEN & CONTROL is an FDA 510(k)-cleared medical device (K802934) manufactured by Orion Diagnostica, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on December 30, 1980. Regulation: 8.