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China NMPA legacy archive 浙械注准20252401017

B型钠尿肽测定试剂盒（电化学发光法）

Ningbo Ruiyuan Biotechnology Co., Ltd.Class IINMPAApproved January 06, 2025
Static archiveNMPA · legacy registration snapshot
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
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。

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
About this record

This static archive preserves historical registration fields and translations for B型钠尿肽测定试剂盒（电化学发光法）, registration 浙械注准20252401017. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.