On April 18th, the Administrative Acceptance Service Center of the State Food and Drug Administration issued the Notice on the Issuance of Approvals for Non-registration on April 18, 2016. A total of 17 products in this batch were not registered. (China Medical Device Note: The magic is that the name of the batch and the applicant information are listed again! There are already two batches in front, but they are all only accepted.) The list of non-registration is as follows:
romatographic and use double-antibodyromatographic and use double-antibodysandwich method to detect antigen. Whenthe concentration of antigen in specimen ishigher than the minimum detection limit, theviral antigen will form complexes withlabeled antibodies first. Under chromatogra-phy, the complexes move forward along thenitrocellulose membrane till captured bypre-coated monoclonal antibody ofindetection zone.Through the visible color tointerprete the test results.
Antigen Test Kit,Disposable viral antigen detection kit,Antigen antibody test kit,Disposable virus sampling tube Jiangsu iiLO Biotechnology Co., Ltd. , https://www.sjiilobiotech.com
CFDA is not registered for 17 products