Human phosphorylated Tau-181 protein detection test kit (chemiluminescence immunoassay) - NMPA Registration 皖械注准20232400179
Access comprehensive regulatory information for Human phosphorylated Tau-181 protein detection test kit (chemiluminescence immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 皖械注准20232400179 and owned by Anhui Iprocom Biotechnology Co., Ltd.. The device was approved on September 21, 2023.
This page provides complete registration details including registrant information, province location (Anhui), 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 to detect the content of human phosphorylated Tau-181 protein (P-Tau-181) in human serum or plasma.
用于检测人体血清或血浆中人磷酸化Tau-181 蛋白(P-Tau-181）的含量。
R1 Biotin-labeled P-Tau-181 murine anti-human monoclonal antibody 0.5 mg/L TRIS buffer 100 mmol/L Preservatives 0.1% R2 Acridine ester-labeled P-Tau-181 murine anti-human monoclonal antibody 2.0 mg/L PBS buffer 100 mmol/L Preservatives 0.1% M Streptavidin-coated magnetic particles 1.0 g/L PBS buffer 100 mmol/L Preservatives 0.1% Calibrator: human phosphorylated Tau-181 protein recombinant antigen, calf serum, preservative; Controls: human phosphorylated Tau-181 protein recombinant antigen, calf serum, preservative.
R1 生物素标记的P-Tau-181 鼠抗人单克隆抗体0.5mg/L TRIS 缓冲液100mmol/L 防腐剂0.1% R2 吖啶酯标记的P-Tau-181 鼠抗人单克隆抗体2.0mg/L PBS 缓冲液100mmol/L 防腐剂0.1% M 链霉亲和素包被的磁微粒1.0g/L PBS 缓冲液100mmol/L 防腐剂0.1% 校准品：人磷酸化Tau-181蛋白重组抗原、小牛血清、防腐剂； 质控品：人磷酸化Tau-181蛋白重组抗原、小牛血清、防腐剂。
Unopened reagents, calibrators and quality controls were stored at 2 °C~8 °C in the dark for 12 months After opening the reagent, store at 2 °C ~ 8 °C in the dark for 28 days After reconstitution, the calibrator was stored at -20°C in the dark for 28 days After reconstitution, the control was stored at -20°C for 28 days Position the kit vertically to ensure that the magnetic particles are fully effective during automatic mixing before use. Storage conditions Expiry date Unopened reagents, calibrators and quality controls were stored at 2 °C ~ 8 °C in the dark for 12 months After the reagent is opened, it is stored at 2 °C ~ 8 °C in the dark for 28 days After reconstitution, the calibrator was stored at -20°C in the dark for 28 days After reconstitution of the quality control products, store at -20 °C in the dark for 28 days Position the kit vertically to ensure that the magnetic particles are fully effective during automatic mixing before use.
未开封试剂、校准品、质控品在2℃～8℃避光保存12 个月 试剂开瓶后2℃～8℃避光保存28 天 校准品复溶后-20℃避光保存28 天 质控品复溶后-20℃避光保存28 天 请垂直摆放试剂盒，确保使用前自动混匀过程中磁微粒完全有效。储存条件 有效期 未开封试剂、校准品、质控品在2℃～8℃避光保存 12个月 试剂开瓶后2℃～8℃避光保存 28天 校准品复溶后-20℃避光保存 28天 质控品复溶后-20℃避光保存 28天 请垂直摆放试剂盒，确保使用前自动混匀过程中磁微粒完全有效。