Da An Gene secures new medical device registration for detection analyzer

Guangzhou Da An Gene Co., Ltd. (Da An Gene) recently obtained a medical device registration certificate from the National Medical Products Administration. The newly registered "Automated Nucleic Acid Detection Analyzer" has a registration number that validates the certificate until October 26, 2030.

This analyzer uses magnetic bead extraction and real-time fluorescence PCR detection principles. It is intended for clinical use with complementary detection reagents for qualitative and quantitative analysis of target nucleic acids (DNA/RNA) from human samples, covering both pathogen and human gene projects.

The company stated that acquiring this certificate enriches its product combination and broadens the application scope of its offerings. However, Da An Gene cautions investors that the product is currently in the market development phase, and market demand presents uncertainties, advising attention to investment risks.