the company obtained three product medical device registration certificates (in vitro diagnostic reagents) for β 2-microglobulin (β 2-MG) detection kit (fluorescence immunoassay) (E-Xie Zhuzhun 20252405361)
On 03 02, 2025On February 8th, Wuhan Xurui Biotechnology Co., Ltd. was established with a registered capital of 10 million yuan.
On 09 19, 2024The development project of the company's chromatographic diagnostic reagent product was successfully completed in January, and the environmental protection passed the expert group acceptance organized by the Emergency Management Bureau of Donghu New Technology Development Zone in Wuhan. On March 25th, the company obtained registration certificates for three medical devices (in vitro diagnostic reagents): D-Dimer detection kit (colloidal gold method) (E-Jiao Zhuzhun 20242404861), cardiac troponin I (cTnI) detection kit (colloidal gold method) (E-Jiao Zhuzhun 20242404860), and insulin-like growth factor binding protein-1 (IGFBP-1) detection kit (colloidal gold method) (E-Jiao Zhuzhun 20242404859). On August 28th, the company obtained the medical device registration certificates (in vitro diagnostic reagents) for the neutrophil gelatinase associated lipocalin (NGAL) detection kit (colloidal gold method) (E equipment injection standard 20242405154) and β 2-microglobulin (β 2-MG) detection kit (colloidal gold method) (E equipment injection standard 20242405155).
On 09 17, 2024On May 15th, the company obtained the medical device registration certificate (in vitro diagnostic reagent) for its first product, the Urine Microalbumin Detection Kit (Colloidal Gold Method), with registration certificate number: EXie Zhuzhun 202322404315. The expected use of this product is for in vitro qualitative detection of albumin in human urine samples. On June 13th, the company obtained the Medical Device Production License (EYJX Production License No. 20231238) issued by the Hubei Provincial Drug Administration, with a production scope of Class II, 6840 in vitro diagnostic reagents.
On 09 17, 2024The company's new chromatographic diagnostic reagent product development project has obtained the record certificate of fixed assets investment project in Hubei Province. After the project is completed, it will produce 10 million diagnostic reagents annually.
On 09 17, 2024