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China NMPA legacy archive 鲁械注准20252400040

Composite quality control material for heart failure markers

心衰标志物复合质控品
Shandong Kanghua Biotechnology Co., Ltd.Class IINMPAApproved January 23, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
规格1：水平1：5×0.5mL、水平2：5×0.5mL； 规格2：水平1：1×0.5mL、水平2：1×0.5mL。
Approval department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration information
Registration number
鲁械注准20252400040
Approval date
January 23, 2025
Expiry date
January 22, 2030
Registrant
Name
Shandong Kanghua Biotechnology Co., Ltd.
山东康华生物医疗科技股份有限公司
Province/Region
Shandong
山东
Address
No. 699, Yuehe Road, Weifang Economic Development Zone
潍坊经济开发区月河路699号
Production facility
Production address
潍坊经济开发区古亭街8877号
Intended use
English

适用于山东康华生物医疗科技股份有限公司的N末端B型脑钠肽前体（NT-proBNP）测定试剂盒（磁微粒化学发光法）、脑利钠肽（BNP）测定试剂盒（磁微粒化学发光法），青岛汉唐生物科技有限公司的N端-B型钠尿肽前体（NT-proBNP）检测试剂盒（干式免疫荧光法）、B型钠尿肽（BNP）测定试剂盒（免疫荧光法）检测时的质量控制。

Structure and composition
English

质控品（冻干）（水平1、水平2）：含B型脑利钠肽（BNP）合成抗原、N末端B型脑钠肽前体（NT-proBNP）大肠杆菌重组抗原；基质为含牛血清白蛋白的基质液，冻干品。质控品靶值具有批特异性，具体范围见靶值单。

Storage conditions and expiration
English

Store at -20°C with a validity period of 12 months.

中文

-20℃条件下储存，有效期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 Composite quality control material for heart failure markers, registration 鲁械注准20252400040. 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.