Transparent Life: Application for medical device registration has been accepted.

Announcement of TransGen Life: The medical device registration application submitted by TransGen Diagnostics Technology Co., Ltd., a company and its wholly-owned subsidiary, has recently been accepted by the Shanghai Food and Drug Administration. The accepted products include cancer embryonic antigen, cytokeratin 19 fragment, neuron-specific enolase, squamous epithelial cell carcinoma antigen, gastrin releasing peptide precursor assay kit, 25-hydroxy vitamin D assay kit, anti-double stranded DNA antibody, anti-C1q antibody, anti-M2-3E antibody, anti-nucleosome antibody, and anti-phospholipid syndrome IgA antibody assay kit, totaling 7 products. These products cover various areas such as tumor detection, metabolism detection, and autoimmune detection, which will help enrich the company's product line layout, meet market demand, and improve market competitiveness. The current stage of approval is the registration application acceptance stage, and the subsequent approval process includes technical evaluation, administrative approval, and issuance of approval documents. The acceptance of the registration application for the above-mentioned products will not have any impact on the recent performance of the company and TransGen Diagnostics.