China NMPA legacy archive 京械注准20242400673

High-density lipoprotein cholesterol test kit (direct method - peroxidase clearing method)

Name: High-density lipoprotein cholesterol test kit (direct method - peroxidase clearing method) — NMPA archive 京械注准20242400673
Creator: Beijing Strong Biotechnologies,Inc.
Keywords: High-density lipoprotein cholesterol test kit (direct method - peroxidase clearing method), 高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20242400673, Class II, NMPA registration

高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20242400673
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 high-density lipoprotein cholesterol (HDL-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高密度脂蛋白胆固醇（HDL-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 High-density lipoprotein cholesterol test kit (direct method - peroxidase clearing method), registration 京械注准20242400673. 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.