Full Range C-Reactive Protein/Serum Amyloid A Test Kit (Fluorescence Immunoassay Chromatography) - NMPA Registration 湘械注准20242401027
Access comprehensive regulatory information for Full Range C-Reactive Protein/Serum Amyloid A Test Kit (Fluorescence Immunoassay Chromatography) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20242401027 and owned by Sinocare Inc.. The device was approved on October 30, 2024.
This page provides complete registration details including registrant information, province location (Hunan), 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.
用于体外定量测定人血清、血浆、静脉全血及末梢血中的C反应蛋白和血清淀粉样蛋白A的含量.
用于体外定量测定人血清、血浆、静脉全血及末梢血中的C反应蛋白和血清淀粉样蛋白A的含量。
规格A:由测试卡、吸滴杯(含样本缓冲液)、取样器(选配)、质控品(冻干粉,含复溶液,选配)和二维码(含校准曲线)组成;规格B:由测试卡、质控品(冻干粉,含复溶液,选配)和二维码(含校准曲线)组成.
规格A:由测试卡、吸滴杯(含样本缓冲液)、取样器(选配)、质控品(冻干粉,含复溶液,选配)和二维码(含校准曲线)组成;规格B:由测试卡、质控品(冻干粉,含复溶液,选配)和二维码(含校准曲线)组成。
原包装试剂在2℃～30℃条件下有效期为18个月,质控品2℃～8℃条件下存放有效期为18个月.原包装试剂不可冷冻,测试卡铝箔袋开封后有效期为1小时,质控品复溶后,2℃～8℃避光条件下可保存24h.
原包装试剂在2℃～30℃条件下有效期为18个月，质控品2℃～8℃条件下存放有效期为18个月。原包装试剂不可冷冻，测试卡铝箔袋开封后有效期为1小时，质控品复溶后，2℃～8℃避光条件下可保存24h。