Folic acid (FA) determination reagent kit (magnetic microparticle chemiluminescence method) - NMPA Registration 粤械注准20242401337
Access comprehensive regulatory information for Folic acid (FA) determination reagent kit (magnetic microparticle 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20242401337 and owned by Shenzhen AmTech Bioengineering Ltd,Inc. The device was approved on October 09, 2024.
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It is used for in vitro quantitative detection of folic acid content in human serum, and is mainly used for the auxiliary diagnosis of megaloblastic anemia in clinical practice.
用于体外定量检测人血清中叶酸的含量，临床上主要用于巨幼红细胞性贫血的辅助诊断。
The kit is composed of streptavidin magnetic bead reagent, acridine marker reagent, biotinylated folic acid reagent, dissociation agent 1, dissociation agent 2, calibrator (optional), and quality control (optional), and the main components are as follows: 1. Streptavidin magnetic bead reagent: Tris, BSA, streptavidin-coated magnetic beads; 2. Acridine conjugate reagents: PBS, BSA, acridine conjugated folic acid antibody (murine source); 3. Biotinylated folic acid reagents: Tris, BSA, DMSO, biotinylated folic acid; 4. Dissociation agent 1: PBS; 5. Dissociation agent 2: Tris, NaCl; 6. Calibrators, quality controls: MES, BSA, folic acid.
试剂盒由链霉亲和素磁珠试剂、吖啶标记物试剂、生物素化叶酸试剂、解离剂1、解离剂2、校准品（选配）、质控品（选配）组成，主要成分如下： 1.链霉亲和素磁珠试剂：Tris，BSA，链霉亲和素包被的磁珠； 2.吖啶标记物试剂：PBS，BSA，吖啶标记的叶酸抗体（鼠源）； 3.生物素化叶酸试剂：Tris，BSA，DMSO，生物素化叶酸； 4.解离剂1：PBS； 5.解离剂2：Tris，NaCl； 6.校准品、质控品：MES，BSA，叶酸。
This kit is stored at 2~8 °C in the dark, forbidden to freeze, and the validity period is 12 months. 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 the bottle; 2~8°C can be stable for 7 days.
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。