Recently, the ANNO-Dx200 Fully Automated Fluorescence Immunoassay Analyzer (Beijing Medical Device Registration No. 20252221011) and the ANNO-Dx200S Fully Automated Fluorescence Immunoassay Analyzer (Beijing Medical Device Registration No. 20252221023), developed by Annoroad Gene Technology (Beijing) Co., Ltd. based on fluorescence immunoassay technology, have officially obtained Medical Device Registration Certificates approved by the Beijing Medical Products Administration.

The Annoroad Fully Automated Fluorescence Immunoassay Analyzer features high detection sensitivity, enabling the identification of low-abundance biomarkers. Its fully automated workflow minimizes manual operational errors, while the ultra-high molecular signal resolution ensures precise quantification.

Both approved fluorescence immunoassay analyzers are designed for use with Annoroad's previously approved "Amyloid-Beta 1-42(Aβ1-42) Assay Kit (Magnetic Particle-based Fluorescence Assay) (Beijing Medical Device Registration No. 20252400942)" and "Phosphorylated tau-181 (p-tau 181) Assay Kit (Magnetic Particle-based Fluorescence Assay) (Beijing Medical Device Registration No. 20252400969)". This integrated system leverages the technical advantages of fluorescence immunoassay to advance early screening and diagnosis of Alzheimer's disease. It offers flexible options tailored to varying throughput and spatial requirements in diverse application settings, thereby providing valuable information to support clinical decision-making.