China NMPA legacy archive 京械注准20242400675

低密度脂蛋白胆固醇测定试剂盒(直接法—过氧化物酶清除法)

Name: 低密度脂蛋白胆固醇测定试剂盒(直接法—过氧化物酶清除法) — NMPA archive 京械注准20242400675
Creator: Beijing Strong Biotechnologies,Inc.
Keywords: 低密度脂蛋白胆固醇测定试剂盒(直接法—过氧化物酶清除法), 低密度脂蛋白胆固醇测定试剂盒（直接法—过氧化物酶清除法）, 京械注准20242400675, Class II, NMPA registration

低密度脂蛋白胆固醇测定试剂盒（直接法—过氧化物酶清除法）

Beijing Strong Biotechnologies,Inc.Class IINMPAApproved November 12, 2024

Static archiveNMPA · legacy registration snapshot

Device classification

Device class: Class II
Model specifications: 610测试/盒;586测试/盒;试剂1:2;55mL、试剂2:2;22mL;试剂1:2;53mL、试剂2:2;21mL.质控品(水平1):1;1mL.质控品(水平2):1;1mL.
Approval department: Beijing Municipal Drug Administration

Registration information

Registration number: 京械注准20242400675
Approval date: November 12, 2024
Expiry date: November 11, 2029

Registrant

Name: Beijing Strong Biotechnologies,Inc.
Province/Region: Beijing
Address: 5th floor, Kuanyi Building, No. 15 Huayuan East Road, Haidian District, Beijing

Production facility

Production address: 北京市怀柔区雁栖经济开发区雁栖北二街15号

Intended use

English

This kit is used for the in vitro quantitative determination of low-density lipoprotein cholesterol (LDL-C) in human serum or plasma.

中文

本试剂盒用于体外定量测定人血清或血浆中低密度脂蛋白胆固醇（LDL-C）的含量。

Structure and composition

English

Note: The target batch of the control is specific, see the target value list for details.

中文

注：质控品靶值批特异，详见靶值单。

Storage conditions and expiration

English

2 °C ~ 8 °C sealed and protected from light, valid for 18 months.

中文

2℃~8℃密封避光保存，有效期18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 低密度脂蛋白胆固醇测定试剂盒(直接法—过氧化物酶清除法), registration 京械注准20242400675. 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.