QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK

QM300 ANTISTREPTOLYSIN O (ASO) ANTIGEN PACK is an FDA 510(k)-cleared medical device (K910886) manufactured by Kallestad Diag, A Div. of Erbamont, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on June 16, 1991. Regulation: 8.