RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE

RUBELLA IGG ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO DIAGNOSTIC DEVICE is an FDA 510(k)-cleared medical device (K951359) manufactured by Bayer Corp.. This device is classified under the Microbiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 14, 1996. Regulation: 8.