Neuron-Specific Enolase (NSE) Determination Reagent Kit (Chemiluminescence Method) - NMPA Registration 粤械注准20242400527
Access comprehensive regulatory information for Neuron-Specific Enolase (NSE) Determination Reagent Kit (Chemiluminescence Method) 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20242400527 and owned by Shenzhen AmTech Bioengineering Ltd,Inc. The device was approved on April 15, 2024.
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 used for in vitro quantitative determination of neuron-specific enolase (NSE) content in human serum, and is clinically used for the treatment monitoring and recurrence monitoring of small cell lung cancer and neuroblastoma. It cannot be used as the basis for early diagnosis or diagnosis of malignant tumors, and should not be used for tumor screening in the general population.
用于体外定量测定人血清中的神经元特异性烯醇化酶（NSE）的含量，临床上用于小细胞肺癌和神经母细胞瘤等的治疗监测和监测复发。不能作为恶性肿瘤早期诊断或确诊的依据，不宜用于普通人群的肿瘤筛查。
The kit is composed of magnetic bead marker reagent, acridine marker reagent, calibrator (2 levels, optional), and quality control (2 levels, optional), and the main components are as follows: Magnetic Bead Marker Reagent: 0.1 M Tris, 0.5% BSA, magnetic bead-coated neuron-specific enolase monoclonal antibody (mouse source) (1.0-1.5 μg/mL). 2. Acridine marker reagent: 0.1 M PBS, 0.5% BSA, acridine-labeled neuron-specific enolase monoclonal antibody (mouse source) (1.0-1.5 μg/mL). 3. Calibrator, QC: 0.1M PBS, 2.0% BSA, neuron-specific enolase antigen (recombinant).
试剂盒由磁珠标记物试剂、吖啶标记物试剂、校准品（2个水平，选配）、质控品（2个水平，选配）组成，主要成分如下： 1. 磁珠标记物试剂：0.1M Tris，0.5% BSA，磁珠包被的神经元特异性烯醇化酶单克隆抗体（鼠源）（1.0-1.5 μg/mL）。 2. 吖啶标记物试剂：0.1M PBS，0.5% BSA，吖啶标记的神经元特异性烯醇化酶单克隆抗体（鼠源）（1.0-1.5 μg/mL）。 3. 校准品、质控品：0.1M PBS，2.0% BSA，神经元特异性烯醇化酶抗原（重组）。
This kit is stored at 2~8 °C in the dark, forbidden to freeze, and the validity period is 12 months. The reagent can be stable for 28 days at 2~8°C after opening the bottle. After the reagent is opened, it can be stable at 2~15 °C for 28 days. The calibrators and quality controls are stored at 2~8°C in the dark, and the validity period is 12 months. Calibrators and quality controls can be stable for 4 hours at 20~25°C after opening, 2~8°C for 28 days, and 20°C for 3 months (freeze-thaw once).
本试剂盒在2～8℃避光贮存，禁止冷冻，有效期为12个月。试剂开瓶后2～8℃可稳定28天。试剂开封后在机2～15℃可稳定28天。校准品和质控品在2~8℃避光贮存，有效期为12个月。校准品、质控品开瓶后20～25℃可稳定4小时，2～8℃可稳定28天，20℃可稳定3个月（可冻融1次）。