Pepsinogen I/Pepsinogen II Assay Kit (Fluorescence Immunochromatography)
- Device class
- Class II
- Model specifications
- Getein1100/Getein1180/Getein1150/Getein1160/Getein200/Getein208:1人份/盒,3人份/盒,5人份/盒,10人份/盒,25人份/盒,50人份/盒,100人份/盒;Getein1200/Getein1600/Getein3200/Getein3208/Getein3600/Getein3608:1×5人份/盒,2×5人份/盒,3×5人份/盒,4×5人份/盒,1×10人份/盒,2×10人份/盒,3×10人份/盒,4×10人份/盒,1×12人份/盒,2×12人份/盒,212人份/盒,,210人份/盒,410人份/盒,212人份/盒,210人份/盒,410人份/盒,112人份/盒,212人份/盒,210人份/盒,410人份/盒,212人份/盒,212人份/盒,210人份/盒,410人份/盒,212人份/盒,210人份/盒,410人份/盒,212人份/盒,212人份/盒,210人份/盒,410人份/盒,112人份/盒,212人份/盒,212人份/盒,210人份/盒,210人份/盒,112人份/盒,23×12人份/盒,4×12人份/盒,1×15人份/盒,2×15人份/盒,3×15人份/盒,4×15人份/盒,1×20人份/盒,2×20人份/盒,3×20人份/盒,4 ×-20人份/盒,1×24人份/盒,2×24人份/盒,3×24人份/盒,4×24人份/盒,1×30人份/盒,2×30人份/盒,3×30人份/盒,4×30人份/盒,1×40人份/盒,2×40人份/盒,3×40人份/盒,4×40人份/盒,1×48人份/盒,2×48人份/盒,3×48人份/盒,4×48人份/盒.
- Approval department
- Jiangsu Provincial Drug Administration
- Registration number
- 苏械注准20242401739
- Approval date
- August 30, 2024
- Expiry date
- August 29, 2029
- Province/Region
- Jiangsu
- Address
- No. 9, Bofu Road, Yanjiang Industrial Development Zone, Liuhe District, Nanjing
- Production address
- 南京市六合区沿江工业开发区博富路9号,南京市江北新区科丰路6号
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。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Pepsinogen I/Pepsinogen II Assay Kit (Fluorescence Immunochromatography), registration 苏械注准20242401739. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.