Pepsinogen I./Pepsinogen II./Gastrin 17 Combined Detection Kit (Dry Immunofluorescence Luminescence Method) - NMPA Registration 鲁械注准20242400891
Access comprehensive regulatory information for Pepsinogen I./Pepsinogen II./Gastrin 17 Combined Detection Kit (Dry Immunofluorescence Luminescence 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 鲁械注准20242400891 and owned by Qingdao Hightop Biotech Co., Ltd.. The device was approved on September 23, 2024.
This page provides complete registration details including registrant information, province location (Shandong), 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 the content of pepsinogen I (PG I), PEPSINOGEN II (PG II), and gastrin 17 (G-17) in human serum, plasma or whole blood.
用于体外定量测定人血清、血浆或全血中胃蛋白酶原 I（PG I）、胃蛋白酶原II（PG II）、胃泌素17（G-17）的含量。
The kit consists of a detection plate, detection buffer (200 μL/test), and a chip. The test plate is composed of a plastic plate and a slat, and the composition of the slats is a PVC board, a sample pad, a nitrocellulose membrane, and an upper absorbent paper. The slats contain fluorescently labeled PGI. monoclonal antibody, PGII. monoclonal antibody and G-17 monoclonal antibody; The detection area included PGI. monoclonal antibody, PGII. monoclonal antibody and G-17 monoclonal antibody. The QC contains a goat anti-mouse IgG polyclonal antibody. The main components of the assay buffer are phosphate, protein stabilizer, and 0.1% Tween. Chip storage information includes: basic project information, batch information, and calibration curves.
试剂盒由检测板、检测缓冲液（200μL/测试）、芯片组成。检测板由塑料板块和板条组成，板条的组成成分是PVC板、样品垫、硝酸纤维素膜、上端吸水纸。其中板条包含荧光标记的PGⅠ单克隆抗体、PGⅡ单克隆抗体及G-17单克隆抗体；检测区包含PGⅠ单克隆抗体、PGⅡ单克隆抗体及G-17单克隆抗体；质控区包含羊抗鼠IgG多克隆抗体。检测缓冲液主要成分是磷酸盐、蛋白稳定剂和0.1%吐温。芯片储存信息包括：项目基本信息、批次信息和校准曲线。
Store at 2~30°C and have an expiration date of 24 months.
2～30°C保存，有效期 24 个月。