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B型钠尿肽测定试剂盒(电化学发光法) - NMPA Registration 浙械注准20252401017

Access comprehensive regulatory information for B型钠尿肽测定试剂盒(电化学发光法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 浙械注准20252401017 and owned by Ningbo Ruiyuan Biotechnology Co., Ltd.. The device was approved on January 06, 2025.

This page provides complete registration details including registrant information, province location (Zhejiang), 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
浙械注准20252401017
B型钠尿肽测定试剂盒(电化学发光法)
NMPA Registration Number: 浙械注准20252401017
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Intended Use
English

This kit is used for the in vitro quantitative determination of the concentration of B-type natriuretic peptide in human plasma.

中文

本试剂盒用于体外定量测定人血浆中B型钠尿肽的浓度。

Device Classification
Device Class
Class II
Model Specifications
100 tests/box; 2×100 tests/box; 3×100 tests/box; 4×100 tests/box; 300 tests/box; 2×300 tests/box; 3×300 tests/box; 4×300 tests/box.
100测试/盒;2×100测试/盒;3×100测试/盒;4×100测试/盒;300测试/盒;2×300测试/盒;3×300测试/盒;4×300测试/盒。
Approval Department
Zhejiang Provincial Drug Administration
浙江省药品监督管理局
Registration Information
Registration Number
浙械注准20252401017
Approval Date
January 06, 2025
Expiry Date
January 05, 2030
Registrant
Name
Ningbo Ruiyuan Biotechnology Co., Ltd.
宁波瑞源生物科技有限公司
Province/Region
Zhejiang
浙江
Address
No. 288, Huangjipu Road, Jiangbei District, Ningbo City
宁波市江北区皇吉浦路288号
Production Facility
Production Address
宁波市江北区皇吉浦路288号
Structure and Composition
English

固相试剂、生物素化试剂、钌标记试剂、校准品(Cal1、Cal2)、质控品(L、M、H)。(具体内容详见说明书)

Storage Conditions and Expiration
English

试剂在2~8℃避光条件下直立保存,可稳定12个月。 校准品和质控品贮存于2~8℃,避光保存可稳定12个月。

Additional Information
Appendix
产品技术要求、说明书