IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120

IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120 is an FDA 510(k)-cleared medical device (K963055) manufactured by Genbio. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on May 1, 1997. Regulation: 8.