Total Protein Assay Kit (Biuret Method) - NMPA Registration 沪械注准20222400131
Access comprehensive regulatory information for Total Protein Assay Kit (Biuret Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 沪械注准20222400131 and owned by Shanghai Fosun LONG March MEDICAL Science Co., Ltd.. The device was approved on August 19, 2022.
This page provides complete registration details including registrant information, province location (Shanghai), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.
It is used by medical institutions for the in vitro quantitative detection of the total protein concentration in human serum or plasma samples for auxiliary diagnosis.
供医疗机构用于对人血清或血浆样本中总蛋白浓度的体外定量检测，作辅助诊断用。
Reagent 1 (R1): potassium sodium tartrate, sodium hydroxide; Reagent 2 (R2): copper sulfate, potassium sodium tartrate, potassium iodide, sodium hydroxide.
试剂1（R1）：酒石酸钾钠、氢氧化钠；试剂2（R2）：硫酸铜、酒石酸钾钠 、 碘化钾、氢氧化钠 。
1. Under the storage conditions of 2~8 °C protected from light and sealed, the kit is valid for 18 months from the date of production. 2. After the reagent is enabled, it can be stable for 15 days under the condition of 2~10 °C in the dark. 3. The production date and expiration date are shown on the kit label.
1.在2～8℃避光、密封的储存条件下，试剂盒自生产之日起有效期为18个月。2.试剂启用后，在2～10℃避光的条件下可稳定15天。3.生产日期和失效日期见试剂盒标签。