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Gastrin 17 determination kit (chemiluminescence immunoassay with magnetic microspheres) - NMPA Registration 京械注准20232400490

Access comprehensive regulatory information for Gastrin 17 determination kit (chemiluminescence immunoassay with magnetic microspheres) 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20232400490 and owned by Beijing Tigsun Diagnostics Co., Ltd.. The device was approved on July 31, 2023.

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.

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Class II
京械注准20232400490
Gastrin 17 determination kit (chemiluminescence immunoassay with magnetic microspheres)
胃泌素17测定试剂盒 (磁微粒化学发光免疫分析法)
NMPA Registration Number: 京械注准20232400490
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Intended Use
English

This product is used for the in vitro quantitative determination of the content of gastrin 17 (G-17) in human serum.

中文

该产品用于体外定量测定人血清中胃泌素17(G-17)的含量。

Device Classification
Device Class
Class II
Model Specifications
50 servings/box, 100 servings/box, 200 servings/box.
50人份/盒、100人份/盒、200人份/盒。
Approval Department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration Information
Registration Number
京械注准20232400490
Approval Date
July 31, 2023
Expiry Date
July 30, 2028
Registrant
Name
Beijing Tigsun Diagnostics Co., Ltd.
北京泰格科信生物科技有限公司
Province/Region
Beijing
北京
Address
Building 1, No. 16, District 1, Guba Road, Chengguan Street, Fangshan District, Beijing
北京市房山区城关街道顾八路一区16号1幢
Production Facility
Production Address
北京市房山区城关街道顾八路一区16号1幢
Structure and Composition
English

Note: The target batch of calibrators and quality control products is specific, and the specific calibrator concentration and quality control range are shown in the bottle label.

中文

注:校准品、质控品靶值批特异,具体校准品浓度及质控范围见瓶签。

Storage Conditions and Expiration
English

The kit is stored at 2 °C ~ 8 °C with an expiration date

中文

试剂盒2℃~8℃储存,有效期

Additional Information
Appendix
产品技术要求、说明书