Cardiac Troponin I/Myoglobin/Creatine Kinase-MB Triple Determination Reagent Kit (Quantum Dot Fluorescence Immunoassay) - NMPA Registration 粤械注准20232400549
Access comprehensive regulatory information for Cardiac Troponin I/Myoglobin/Creatine Kinase-MB Triple Determination Reagent Kit (Quantum Dot Fluorescence 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 粤械注准20232400549 and owned by Labnovation Technologies,inc.. The device was approved on April 03, 2023.
This page provides complete registration details including registrant information, province location (Guangdong), 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 suitable for the quantitative detection of cardiac troponin I (cTnI), myoglobin (Myo), creatine kinase isoenzyme (CK-MB) in human serum/plasma/whole blood in vitro clinical vitro. Clinically, it is mainly used for the auxiliary diagnosis of myocardial infarction.
适用于临床体外定量检测人血清/血浆/全血中的心肌肌钙蛋白 I（cTnI）、肌红蛋白（Myo）、肌酸激酶同工酶（CK-MB）的含量。临床上主要用于心肌梗死的辅助诊断。
The kit is mainly composed of a test card, sample diluent, and IC card (optional). Thereinto: 1. The test card is composed of test strips and plastic card shells. The main components on the test strip are: marking pad, nitrocellulose membrane, absorbent paper, PVC board. The nitrocellulose membrane is coated with murine anti-human cTnI monoclonal antibody, mouse anti-human Myo monoclonal antibody, murine anti-human CK-MB monoclonal antibody and sheep anti-rabbit IgG. The labeling pad mainly contains fluorescently labeled murine anti-human cTnI monoclonal antibody, murine anti-human Myo monoclonal antibody, murine anti-human CK-MB monoclonal antibody and rabbit IgG. 2. The main components of the sample diluent are Tris buffer and surfactant.
试剂盒主要由检测卡、样本稀释液、IC卡（选配）组成。其中： 1.检测卡由试纸条、塑料卡壳组成。试纸条上的主要成分有：标记垫、硝酸纤维素膜、吸水纸、PVC板。硝酸纤维素膜包被有鼠抗人cTnI单克隆抗体、鼠抗人Myo单克隆抗体、鼠抗人CK-MB单克隆抗体和羊抗兔IgG；标记垫上主要有荧光标记的鼠抗人cTnI单克隆抗体、鼠抗人Myo单克隆抗体、鼠抗人CK-MB单克隆抗体和兔IgG。 2.样本稀释液主要成分为Tris缓冲液及表面活性剂。
The kit is stored at 2~30 °C in the dark, moisture-proof and avoid heavy pressure, and the validity period is 18 months; After the detection card foil bag is opened, it should be used as soon as possible within 1 hour under the condition of 18-28 ° C and 40-60% humidity.
试剂盒于 2～30℃避光、防潮保存并避免重压，有效期为18个月；检测卡铝箔袋开封后，在18-28℃，40-60%湿度条件下，应在1小时内尽快使用。