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Calcitonin (CT) detection kit (fluorescence immunoassay chromatography) - NMPA Registration 京械注准20242400005

Access comprehensive regulatory information for Calcitonin (CT) detection kit (fluorescence immunoassay chromatography) 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20242400005 and owned by Beijing Savant Biotechnology Co., Ltd.. The device was approved on January 10, 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.

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Class II
京械注准20242400005
Calcitonin (CT) detection kit (fluorescence immunoassay chromatography)
降钙素(CT)测定试剂盒(荧光免疫层析法)
NMPA Registration Number: 京械注准20242400005
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Pricing
Intended Use
English

This kit is used for the quantitative determination of calcitonin (CT) content in human serum, plasma and whole blood in vitro.

中文

本试剂盒用于体外定量测定人血清、血浆和全血中降钙素(CT)的含量。

Device Classification
Device Class
Class II
Model Specifications
10 servings/box, 20 servings/box, 50 servings/box.
10人份/盒、20人份/盒、50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20242400005
Approval Date
January 10, 2024
Expiry Date
January 09, 2029
Registrant
Name
Beijing Savant Biotechnology Co., Ltd.
北京华科泰生物技术股份有限公司
Province/Region
Beijing
北京
Address
101-301, 302, 3rd Floor, Building 4, No. 8 Liangshuihe 2nd Street, Beijing Economic and Technological Development Zone, Beijing (Yizhuang Group, High-end Industrial Area, Beijing Pilot Free Trade Zone)
北京市北京经济技术开发区凉水河二街8号院4号楼3层101-301、302(北京自贸试验区高端产业片区亦庄组团)
Production Facility
Production Address
北京市北京经济技术开发区凉水河二街8号院4号楼3层101-302
Structure and Composition
English

Test card, calibration information card, quality control (optional), sample diluent (optional), centrifuge tube (optional), desiccant.

中文

检测卡、校准信息卡、质控品(选配)、样本稀释液(选配)、离心管(选配)、干燥剂。

Storage Conditions and Expiration
English

试剂盒在10℃~30℃储存(

中文

试剂盒在10℃~30℃储存(

Additional Information
Appendix
产品技术要求、说明书