Rapamycin assay kit (chemiluminescence immunoassay) - NMPA Registration 京械注准20232400530
Access comprehensive regulatory information for Rapamycin assay 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 京械注准20232400530 and owned by Beijing Diagreat Biotechnologies Co., Ltd.. The device was approved on September 01, 2023.
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.
It is used for in vitro quantitative determination of the content of rapamycin in human whole blood.
用于体外定量测定人全血中的雷帕霉素的含量。
name Composition Loading Reagent M Superparamagnetic particles coated with anti-rapamycin antibody, > 0.1 g/L ProClin300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 1 rapamycin-alkaline phosphatase marker, ＞0.1mg/L ProClin300,0.1% Serves 50: 5mL; Serves 100: 10mL Reagent 2 PB buffer Proclin 300,0.1% Serves 50: 5mL; Serves 100: 10mL Reagent 3 PB buffer Proclin 300,0.1% Serves 50: 5mL; Serves 100: 10mL Calibrators (Optional) 3 levels, lyophilized, containing rapamycin, Proclin 300 Target Concentration Range: S1:0-5ng/mL;S2:5-20ng/mL; S3:20-50ng/mL Reconstitute 1 mL volume Calibration information A QR code containing information about the main calibration curve / Note: Calibrator assignment is batch-specific, and the target value of each lot is detailed in the label.
名称 组成成分 装量 试剂M 包被着抗雷帕霉素抗体的超顺磁性微粒，＞0.1g/L ProClin300，0.1% 50人份：3mL； 100人份：6mL 试剂1 雷帕霉素-碱性磷酸酶标记物， ＞0.1mg/L ProClin300，0.1% 50人份：5mL； 100人份：10mL 试剂2 PB缓冲液 Proclin 300，0.1% 50人份：5mL； 100人份：10mL 试剂3 PB缓冲液 Proclin 300，0.1% 50人份：5mL； 100人份：10mL 校准品 （选配） 3水平，冻干品，含雷帕霉素， Proclin 300 目标浓度范围： S1：0-5ng/mL；S2：5-20ng/mL； S3：20-50ng/mL 复溶体积1mL 校准信息 二维码，包含主校准曲线信息 / 注：校准品赋值具有批特异性，每批次靶值详见标签。
The reagents are stored at 2 °C ~ 8 °C
试剂在2℃～8℃条件下存放有