B-type Natriuretic Peptide Reagent Test Kit (Chemiluminescence Immunoassay) - NMPA Registration 皖械注准20242400110
Access comprehensive regulatory information for B-type Natriuretic Peptide Reagent 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20242400110 and owned by Anhui Iprocom Biotechnology Co., Ltd.. The device was approved on August 04, 2024.
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.
This product is used for in vitro quantitative detection of B-type natriuretic peptide content in human plasma samples.
该产品用于体外定量检测人血浆样本中B型利钠肽的含量。
R1: Biotinylated BNP sheep anti-monoclonal antibody 1.0mg/L, TRIS buffer 100mmol/L, preservative 0.10%; R2: 1.0mg/L of acetylate-labeled BNP goat anti-monoclonal antibody, 100mmol/L of PBS buffer, 0.10% preservative; M: Streptavidin-coated magnetic particles 1.0g/L, PBS buffer 100mmol/L, preservative 0.10%; Calibrator: The main components are BNP recombinant antigen, bovine serum albumin, PBS buffer, and lyophilized powder with preservatives, the target concentration of calibrator level 1 is 100 pg/mL, and the target concentration of calibrator level 2 is 2500 pg/mL; Control: Lyophilized powder with BNP recombinant antigen, bovine serum albumin, PBS buffer, and preservatives as the main ingredients, with a target concentration of 100 pg/mL for control level 1 and 2500 pg/mL for control level 2.
R1:生物素标记的BNP羊抗单克隆抗体 1.0mg/L、TRIS 缓冲液 100mmol/L、防腐剂 0.10%； R2:吖碇酯标记的BNP羊抗单克隆抗体 1.0mg/L、PBS 缓冲液100mmol/L、防腐剂 0.10%； M：链霉亲和素包被的磁微粒 1.0g/L、PBS缓冲液 100mmol/L、防腐剂 0.10%； 校准品：主要成分为BNP重组抗原、牛血清白蛋白、PBS缓冲液、防腐剂的冻干粉，校准品水平1目标浓度为100pg/mL，校准品水平2目标浓度为2500pg/mL； 质控品：主要成分为BNP重组抗原、牛血清白蛋白、PBS缓冲液、防腐剂的冻干粉，质控品水平1目标浓度为100pg/mL，质控品水平2目标浓度为2500pg/mL。
Unopened reagents, calibrators, and quality controls can be stored at 2°C ~ 8°C in the dark, forbidden to freeze, and can be stored for 12 months. After the reagent is opened, it is stored at 2°C ~ 8°C for 28 days. The calibrator was stored at 2°C ~ 8°C for 7 days after reconstitution. Position the kit vertically to ensure that the magnetic particles are fully valid during automatic mixing before use. The control was stored at 2°C ~ 8°C for 7 days after reconstitution.
未开封试剂、校准品、质控品在2℃ ~ 8℃避光保存，禁止冷冻，可保存12个月。 试剂开瓶后2℃ ~ 8℃避光保存28天。 校准品复溶后2℃ ~ 8℃保存7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。 质控品复溶后2℃ ~ 8℃保存7天。