GBI TSH NEONATAL SCREENING KIT

GBI TSH NEONATAL SCREENING KIT is an FDA 510(k)-cleared medical device (K072458) manufactured by Golden Bridge International, Inc.. This device is classified under the Clinical Chemistry specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 2008. Regulation: 8.