Pepsinogen I/Pepsinogen II Assay Kit (Fluorescence Immunochromatography) - NMPA Registration 苏械注准20242401739
Access comprehensive regulatory information for Pepsinogen I/Pepsinogen II Assay Kit (Fluorescence Immunochromatography) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 苏械注准20242401739 and owned by Getein Biotech, Inc.. The device was approved on August 30, 2024.
This page provides complete registration details including registrant information, province location (Jiangsu), 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 clinical in vitro quantitative detection of pepsinogen I and pepsinogen II (PGI/PGII) in human serum, plasma or whole blood samples
用于临床体外定量检测人血清、血浆或全血样本中胃蛋白酶原I和胃蛋白酶原II（PGI/PGII）的含量
The kit consists of a test card, test buffer, SD card, instructions, and an optional pipette. Among them: 1. The main components of the detection card: a) PGI monoclonal antibody II (mouse origin, 0.1~0.5 mg/mL) and PGII monoclonal antibody II (mouse origin, 0.3~0.8 mg/mL) coated in the detection area on the NC membrane; b) sheep anti-mouse immunoglobulin G antibody (sheep-derived, 0.3~0.8 mg/mL) coated in the quality control region on the NC membrane; c) Fluorescently labeled PGI monoclonal antibody I (mouse origin, 0.5~1.5 mg/mL) and fluorescently labeled PGII monoclonal antibody I (mouse origin, 0.5~1.5 mg/mL); d) Others: housing, sample pads, absorbent paper and liners. 2. Detection buffer (Getein1100/1150/1160/1180/200/208): 20 mmol/L phosphate buffer, containing 0.1% sodium azide, pH=7.2±0.5, 1mL/tube, packaging specifications are 1 tube/box, 3 tubes/box, 5 tubes/box, 10 tubes/box, 25 tubes/box, 50 tubes/box, 100 tubes/box. 3.SD card: matching Getein 1100/1150/1160/1180/200/208: 1pcs/box; Getein1200/1600/3200/3208/3600/3608: 1 pcs/box, 2 pcs/box, 3 pcs/box, 4 pcs/box. 4. Instruction manual: 1 copy/box. 5. Straw (Getein1100/1150/1160/1180/200/208): optional.
试剂盒由检测卡、检测缓冲液、SD卡、说明书和吸管（选配）组成。其中：1.检测卡主要组成成分：a）包被在NC膜上检测区的PGI单克隆抗体II（小鼠源性，0.1~0.5 mg/mL）和PGII单克隆抗体II（小鼠源性，0.3~0.8 mg/mL）；b）包被在NC膜上质控区的羊抗鼠免疫球蛋白G抗体（羊源性，0.3~0.8 mg/mL）；c）荧光标记的PGI单克隆抗体I（小鼠源性，0.5~1.5 mg/mL）和荧光标记的PGII单克隆抗体I（小鼠源性，0.5~1.5mg/mL）；d）其它：外壳、样品垫、吸水纸和衬垫。2.检测缓冲液（Getein1100/1150/1160/1180/200/208配套）：20 mmol/L磷酸盐缓冲液，含0.1%叠氮钠，pH=7.2±0.5，1mL/管，包装规格为1管/盒、3管/盒、5管/盒、10管/盒、25管/盒、50管/盒、100管/盒。3.SD卡：配套Getein1100/1150/1160/1180/200/208：1个/盒；配套Getein1200/1600/3200/3208/3600/3608：1个/盒、2个/盒、3个/盒、4个/盒。4.说明书：1份/盒。5.吸管（Getein1100/1150/1160/1180/200/208配套）：选配。
Validity period of sealing: The test card is stored at 4~30°C in a sealed state, and the validity period is 18 months. Expiration date: The detection card used with Getein1100/1150/1160/1180/200/208 models is valid for 1 hour after opening (temperature 4~30°C, humidity <80%); After the test card used with Getein1200/1600/3200/3208/3600/3608 model is opened (temperature 4~30°C, humidity <80%), the cumulative time of exposure to air does not exceed 24 hours, and the unused reagents are recommended to be sealed in the original ziplock bag in the kit for 4~30°C storage, and the maximum is not more than 7 days.
密封有效期：检测卡于4~30℃，密封状态下存放，有效期为18个月。开封有效期：配套Getein1100/1150/1160/1180/200/208机型使用的检测卡开封后（温度4~30℃，湿度<80%），有效期为1小时；配套Getein1200/1600/3200/3208/3600/3608机型使用的检测卡开封后（温度4~30℃，湿度<80%），暴露在空气中的累计时长不超过24小时，未使用完的试剂建议使用试剂盒内的原自封包装袋密封4~30℃保存，最长不超过7天。