Amoy Diagnostics Co.,Ltd. (300685.SZ) has announced the receipt of a Medical Device Registration Certificate issued by the National Medical Products Administration. The approved product is the "Human Microsatellite Instability (MSI) Detection Kit (Fluorescent PCR Melting Curve Method)." This kit is designed for the in vitro qualitative detection of microsatellite loci (ACVR2A, PRR5-ARHGAP8, EIF4E3, IFT140, RBM14-RBM4, UBAC2) in FFPE tumor tissue samples from colorectal cancer patients. Based on the number of microsatellite loci exhibiting sequence length changes, the kit classifies colorectal cancer into two microsatellite statuses: microsatellite instability-high (MSI-H) and non-microsatellite instability-high (MSS/MSI-L).