ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION

ORTHO* CHLAMYDIA ANTIGEN ELISA TEST/MODIFICATION is an FDA 510(k)-cleared medical device (K910668) manufactured by Ortho Diagnostic Systems, Inc.. This device is classified under the Microbiology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 18, 1991. Regulation: 8.