QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST

QUIKRESPONSE ONE STEP MIDSTREAM EARLY PREGRANCY TEST is an FDA 510(k)-cleared medical device (K112449) manufactured by Tianjin New Bay Bioresearch Co., Ltd.. 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 September 23, 2012. Regulation: 8.