抗SSB抗体质控品 - NMPA Registration 京械注准20242400250
Access comprehensive regulatory information for 抗SSB抗体质控品 in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400250 and owned by Beijing Bioassay Technologies Corporation. The device was approved on May 14, 2024.
This page provides complete registration details including registrant information, province location (Beijing), 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.
与北京世纪沃德生物科技有限公司生产的抗SSB抗体测定试剂盒（胶乳免疫比浊法）配套使用，用于抗SSB抗体（Anti-SSB）项目的室内质量控制。
组成性状主要成分浓度质控品冻干粉人血清50%磷酸盐缓冲液20mmol/L防腐剂0.03%保护剂5%氯化钠0.15mol/L抗SSB抗体目标浓度范围：水平1：[2.00，50.00]AU/mL水平2：(50.00，200.00]AU/mL质控品质控范围批特异，详见质控品瓶签。
Store at 2°C~8°C in the dark, valid for 18 months.
2℃～8℃避光保存，有效期为18个月。