Gastrin-17 assay kit (latex immunoturbidimetric method)
- Device class
- Class II
- Model specifications
- Reagent 1: 15mL; 1. Reagent 2: 5mL; 1. Reagent 1: 45mL; 1. Reagent 2: 15mL; 1. Reagent 1: 45mL; 3. Reagent 2: 15mL; 3. Reagent 1: 60mL; 1. Reagent 2: 20mL; 1;500 tests/box; 1000 tests/box; Calibrator (optional): 0.5mL; 5 (5 levels); Control Level 1 (optional): 0.5mL; 1. Quality control level 2 (optional): 0.5mL; 1.试剂1：15mL;1、试剂2：5mL;1；试剂1：45mL;1、试剂2：15mL;1；试剂1：45mL;3、试剂2：15mL;3；试剂1：60mL;1、试剂2：20mL;1；500测试/盒；1000测试/盒；校准品（选配）：0.5mL;5（5水平）；质控品水平1（选配）：0.5mL;1；质控品水平2（选配）：0.5mL;1。
- Approval department
- Beijing Municipal Drug Administration北京市药品监督管理局
- Registration number
- 京械注准20242400450
- Approval date
- August 27, 2024
- Expiry date
- August 26, 2029
- Name
- Beijing WantaiDerui Diagnostic Technology Co., Ltd.北京万泰德瑞诊断技术有限公司
- Province/Region
- Beijing北京
- Address
- No. 31 Science Park Road, Changping District, Beijing北京市昌平区科学园路31号
- Production address
- 北京市昌平区科学园路31号1号楼1层102和106，1号楼3层A区、B区、C区，7号楼东侧303、西侧401
It is used for in vitro quantitative determination of the content of gastrin 17 in human serum.
用于体外定量测定人血清中胃泌素17的含量。
试剂1:Tris缓冲液(pH7.0),100mmol/L. 试剂2:Tris缓冲液,50mmol/L;胃泌素17抗体,适量. 校准品:Tris缓冲液(pH7.4),胃泌素17抗原,水平1～水平5目标浓度范围分别为:0pg/mL、5pg/mL～15pg/mL、15pg/mL～25pg/mL、30pg/mL～50pg/mL、70pg/mL～90pg/mL. 质控品:Tris缓冲液(pH7.4),胃泌素17抗原,质控品靶值范围:水平1:11pg/mL～20pg/mL,水平2:25pg/mL～45pg/mL. 校准品、质控品批特异,具体浓度见瓶签.
试剂1：Tris缓冲液（pH7.0），100mmol/L。试剂2：Tris缓冲液，50mmol/L；胃泌素17抗体，适量。校准品：Tris缓冲液（pH7.4），胃泌素17抗原，水平1～水平5目标浓度范围分别为：0pg/mL、5pg/mL～15pg/mL、15pg/mL～25pg/mL、30pg/mL～50pg/mL、70pg/mL～90pg/mL。质控品：Tris缓冲液（pH7.4），胃泌素17抗原，质控品靶值范围：水平1：11pg/mL～20pg/mL，水平2：25pg/mL～45pg/mL。校准品、质控品批特异，具体浓度见瓶签。
2 °C ~ 8 °C storage, valid for 12 months.
2℃～8℃保存，有效期为12个月。
Access comprehensive regulatory information for Gastrin-17 assay kit (latex immunoturbidimetric 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 京械注准20242400450 and owned by Beijing WantaiDerui Diagnostic Technology Co., Ltd.. The device was approved on August 27, 2024.
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.