D-Dimer Test Kit (Quantum Dot Fluorescence Immunoassay) - NMPA Registration 粤械注准20232400485
Access comprehensive regulatory information for D-Dimer Test 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20232400485 and owned by Labnovation Technologies,inc.. The device was approved on March 23, 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 D-dimer (D-Dimer) content in human plasma/whole blood in vitro clinically, and is mainly used clinically for the auxiliary diagnosis of disseminated intravascular coagulation and the monitoring of thrombolytic therapy, and should not be used to exclude venous thrombosis.
适用于临床体外定量检测人血浆/全血中的 D-二聚体（D-Dimer）的含量，临床上主要用于弥散性血管内凝血的辅助诊断以及溶栓治疗的监测，不得用于排除静脉血栓形成。
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. Nitrocellulose membrane coated with murine anti-human D-Dimer monoclonal antibody and sheep anti-rabbit IgG; The labeling pad mainly contains fluorescently labeled murine anti-human D-Dimer 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D-Dimer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D-Dimer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 test card foil bag is opened, it should be used as soon as possible within 1 hour at 18-28°C, 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。