Cancer antigen 72-4 (CA72-4) determination reagent kit (chemiluminescence method) - NMPA Registration 粤械注准20242400532
Access comprehensive regulatory information for Cancer antigen 72-4 (CA72-4) 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20242400532 and owned by Shenzhen AmTech Bioengineering Ltd,Inc. The device was approved on April 18, 2024.
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It is used for in vitro quantitative determination of the content of cancer antigen 72-4 (CA72-4) in human serum, and is mainly used for monitoring the efficacy of malignant tumors such as gastrointestinal system in clinical practice. 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癌抗原72-4（CA72-4）的含量，临床上主要用于胃肠系统等恶性肿瘤的疗效监测。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 streptavidin magnetic separation reagent, acridine marker reagent, biotin marker reagent, calibrator (2 levels, optional), and quality control (2 levels, optional), and the main components are as follows: 1. Streptavidin magnetic separation reagent: 0.1 M Tris, 0.5% BSA, coated with streptavidin magnetic particles. Acridine conjugate reagent: 0.1 M PBS, 0.5% BSA, acridine conjugated cancer antigen 72-4 monoclonal antibody (murine source) (1.0-1.5 μg/mL). Biotin Marker Reagent: 0.1 M Tris, 0.5% BSA, Biotinylated Cancer Antigen 72-4 monoclonal antibody (murine source) (1.0-1.5 μg/mL). 4. Calibrator and quality control: 0.1M MES, 2.0% BSA, cancer antigen 72-4 antigen (human).
试剂盒由链霉亲和素磁分离试剂、吖啶标记物试剂、生物素标记物试剂、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. 链霉亲和素磁分离试剂：0.1M Tris，0.5% BSA，包被链霉亲和素的磁微粒。 2. 吖啶标记物试剂：0.1M PBS，0.5% BSA，吖啶标记的癌抗原72-4单克隆抗体（鼠源）（1.0-1.5 μg/mL）。 3. 生物素标记物试剂：0.1M Tris，0.5% BSA，生物素标记的癌抗原72-4单克隆抗体（鼠源）（1.0-1.5 μg/mL）。 4. 校准品、质控品：0.1M MES，2.0% BSA，癌抗原72-4抗原（人源）。
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. The calibrator and quality control can be stable for 4 hours at 20~25°C after opening, 7 days at 2~8°C, and 3 months at -20°C (1 freeze-thaw time).
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7天；-20℃可稳定3个月（可冻融1次）。