Vitamin B12 Assay Kit (Chemiluminescence Immunoassay) - NMPA Registration 京械注准20232400533
Access comprehensive regulatory information for Vitamin B12 Assay Kit (Chemiluminescence 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 京械注准20232400533 and owned by Beijing Diagreat Biotechnologies Co., Ltd.. The device was approved on September 01, 2023.
This page provides complete registration details including registrant information, province location (Beijing), 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 the in vitro quantitative determination of vitamin B12 content in human serum or plasma.
用于体外定量测定人体血清或血浆中维生素B12的含量。
name Composition Loading capacity Reagent M Superparamagnetic particles coated with VB12 antibody > 0.1 g/L ProClin 300,0.1% Serving 50: 3mL; Serving 100: 6 mL Reagent 1 Intraporcine factor-alkaline phosphatase marker, > 0.1 mg/L ProClin 300,0.1% Serving 50: 3mL; Serving 100: 6 mL Sample treatment solution A Tris buffer, 50 mmol/L ProClin 300,0.1% Serving 50: 3mL; Serving 100: 6 mL Sample treatment solution B NaCl saline solution Serving 50: 3mL; Serving 100: 6 mL Calibrator (Optional) 3 levels, contains human vitamin B12, stabilizer, preservative Target concentration range: Level 1: 0-50 pg/mL; Level 2: 50-1000 pg/mL; Level 3: 1000-5000 pg/mL 1mL Calibration information QR code containing the main calibration curve information / Note: Calibrator assignments are lot-specific, and target values for each lot are detailed on the label.
名称 组成成分 装量 试剂M 包被着VB12抗体的超顺磁性微粒，＞0.1g/L ProClin 300，0.1% 50人份：3mL； 100人份：6mL 试剂1 猪内因子-碱性磷酸酶标记物，＞0.1mg/L ProClin 300，0.1% 50人份：3mL； 100人份：6mL 样本处理液A Tris缓冲液，50mmol/L ProClin 300，0.1% 50人份：3mL； 100人份：6mL 样本处理液B NaCl盐溶液 50人份：3mL； 100人份：6mL 校准品 （选配） 3水平，含人维生素B12，稳定剂，防腐剂 目标浓度范围： 水平1：0-50pg/mL；水平2：50-1000 pg/mL；水平3：1000-5000 pg/mL 1mL 校准信息 二维码，包含主校准曲线信息 / 注：校准品赋值具有批特异性，每批次靶值详见标签。
The reagents are stored at 2 °C ~ 8 °C
试剂在2℃～8℃条件下存放有