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China NMPA legacy archive 京械注准20242400623

β2-microglobulin quality control product

β2-微球蛋白质控品
Biosino BIO-TECHNOLOGY and Science INC.Class IINMPAApproved November 08, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
水平1:1mL;1,水平2:1mL;1.
水平1:1mL;1,水平2:1mL;1。
Approval department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration information
Registration number
京械注准20242400623
Approval date
November 08, 2024
Expiry date
November 07, 2029
Registrant
Name
Biosino BIO-TECHNOLOGY and Science INC.
中生北控生物科技股份有限公司
Province/Region
Beijing
北京
Address
No. 27, Chaoqian Road, Science and Technology Park, Changping District, Beijing
北京市昌平区科技园区超前路27号
Production facility
Production address
北京市昌平区科技园区超前路27号
Intended use
English

与本公司beta;2-微球蛋白测定试剂盒(胶乳免疫比浊法)配套使用,用于临床检验实验室测定尿液样本beta;2-微球蛋白项目的室内质量控制.

中文

与本公司beta;2-微球蛋白测定试剂盒(胶乳免疫比浊法)配套使用,用于临床检验实验室测定尿液样本beta;2-微球蛋白项目的室内质量控制。

Structure and composition
English

磷酸盐缓冲液,10mmol/L;两个水平,目标浓度范围为水平1:0.14mg/L~0.32mg/L;水平2:1.12mg/L~2.08mg/L.每批定值,值有批特异性,详见值单.

中文

磷酸盐缓冲液,10mmol/L;两个水平,目标浓度范围为水平1:0.14mg/L~0.32mg/L;水平2:1.12mg/L~2.08mg/L。每批定值,值有批特异性,详见值单。

Storage conditions and expiration
English

2℃~8℃避光贮存,有效期18个月.

中文

2℃~8℃避光贮存,有效期18个月。

Additional information
Changes
产品过期日期变更为:2℃~8℃避光贮存,有效期18个月。。
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for β2-microglobulin quality control product, registration 京械注准20242400623. 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.