Gastrin 17 calibrator
- Device class
- Class II
- Model specifications
- 6×0.25mL (lyophilized powder, reconstituted volume);6×0.5mL (lyophilized powder, reconstituted volume);6×1.0 mL (lyophilized powder, reconstituted volume);6×2.0 mL (lyophilized powder, reconstituted volume)6×0.25mL（冻干粉，复溶后体积）；6×0.5mL（冻干粉，复溶后体积）；6×1.0 mL（冻干粉，复溶后体积）；6×2.0 mL（冻干粉，复溶后体积）
- Approval department
- Jiangsu Provincial Drug Administration江苏省药品监督管理局
- Registration number
- 苏械注准20232401603
- Approval date
- November 17, 2023
- Expiry date
- November 16, 2028
- Name
- Taizhou Zecen Biotech Co., Ltd.泰州泽成生物技术有限公司
- Province/Region
- Jiangsu江苏
- Address
- Taizhou City, China Medicine City Kou Tai Road, east side of G59 Building No. 62 west half of the west side of the first to fourth floors泰州市中国医药城口泰路西侧、陆家路东侧G59幢62号西半侧一至四层
- Production address
- 泰州市中国医药城口泰路西侧、陆家路东侧G59幢62号西半侧一至四层
It is used for the system calibration of the gastrin 17 detection kit (magnetic particle chemiluminescence method) on the supporting detection system of Taizhou Zecheng Biotechnology Co., Ltd.
用于泰州泽成生物技术有限公司配套检测系统上胃泌素17检测试剂盒（磁微粒化学发光法）项目测定时的系统校准。
The main component of the calibrator is recombinant gastrin 17, which is derived from E. coli and contains a stabilizer (approximately 6% BSA). Calibrator C0: Tris buffer (50 mmol/L, pH 7.5±0.1) with 0% BSA and 0.2% preservative at a concentration of 0 pmol/L, Calibrator C1: Tris buffer with approximately 6% BSA and 0.2% preservative at a concentration of approximately 5 pmol/L at gastrin 17, and Calibrator C2: Approximately 6% BSA at a concentration of approximately 5 pmol/L at a concentration of approximately 5 pmol/L with 0.2% preservative (50 mmol/L, pH 7.5±0.1) and Calibrator C2: Approximately 6% with gastrin 17 at a concentration of approximately 20 pmol/L BSA, 0.2% preservative, Tris buffer (50 mmol/L, pH7.5±0.1), calibrator C3: Tris buffer with approx. 6% BSA, 0.2% preservative, 50 mmol/L, pH 7.5±0.1) at a concentration of approximately 80 pmol/L, Calibrated Substance C4: Tris buffer with approx. 6% BSA, 0.2% preservative, at a concentration of approximately 160 pmol/L gastrin 17 (50 mmol/L, L, PH7.5±0.1), calibrator C5: Tris buffer (50 mmol/L, pH 7.5±0.1) with approximately 6% BSA, 0.2% preservative, at a concentration of approximately 320 pmol/L.
校准品主要成分为重组胃泌素17，来源于大肠杆菌，并含有稳定剂（约6%BSA）。校准品C0：胃泌素17浓度为0 pmol/L的含约6%BSA，0.2%防腐剂的Tris缓冲液（50 mmol/L，PH7.5±0.1）；校准品C1：胃泌素17浓度约为5 pmol/L的含约6%BSA，0.2%防腐剂的Tris缓冲液（50 mmol /L，PH7.5±0.1）；校准品C2：胃泌素17浓度约为20 pmol/L的含约6%BSA，0.2%防腐剂的Tris缓冲液（50 mmol /L，PH7.5±0.1）；校准品C3：胃泌素17浓度约为80 pmol/L的含约6%BSA，0.2%防腐剂的Tris缓冲液（50 mmol /L，PH7.5±0.1）；校准品C4：胃泌素17浓度约为160 pmol/L的含约6%BSA，0.2%防腐剂的Tris缓冲液（50 mmol /L，PH7.5±0.1）；校准品C5：胃泌素17浓度约为320 pmol/L的含约6%BSA，0.2%防腐剂的Tris缓冲液（50 mmol /L，PH7.5±0.1）。
1. This product is freeze-dried, stored at 2~8 °C before opening, and the product is valid for 18 months. 2. After reconstitution, 2 °C ~ 8 °C, can be stored for 7 days, avoid direct sunlight.
1.本品为冻干品，未开封前，2~8℃保存，产品有效期为18个月。2.复溶后2℃～8℃，可保存7天，避免阳光直射。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Gastrin 17 calibrator 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20232401603 and owned by Taizhou Zecen Biotech Co., Ltd.. The device was approved on November 17, 2023.
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.