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China NMPA legacy archive 湘械注准20232400794

Interleukin-12P70 Detection Kit (Chemiluminescence Immunoassay)

白介素-12p70检测试剂盒(化学发光免疫分析法)
Changsha Micron Biotechnology Co., Ltd.Class IINMPAApproved August 18, 2023
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
100 servings/box, 200 servings/box.
100人份/盒、200人份/盒。
Approval department
Hunan Provincial Drug Administration
湖南省药品监督管理局
Registration information
Registration number
湘械注准20232400794
Approval date
August 18, 2023
Expiry date
August 17, 2028
Registrant
Name
Changsha Micron Biotechnology Co., Ltd.
长沙市微米生物科技有限公司
Province/Region
Hunan
湖南
Address
Room 1001, 1002, 1007, 1008, Standard Factory Building, Shanhe Pharmaceutical and Health Industrial Park, No. 1048, Zhongqing Road, Shaping Street, Kaifu District, Changsha
长沙市开福区沙坪街道中青路1048号山河医药健康产业园标准厂房3栋1001、1002、1007、1008房
Production facility
Production address
长沙市开福区沙坪街道中青路1048号山河医药健康产业园第3栋201房
Intended use
English

This product is suitable for the quantitative determination of interleukin-12p70 (IL-12p70) content in human serum or plasma samples in vitro.

中文

本产品适用于体外定量测定人血清或血浆样本中白介素-12p70(IL-12p70)的含量。

Structure and composition
English

The reagent consists mainly of magnetic bead coating (M), biotin marker (R1), acridine ester marker (R2), calibrator (optional) and quality control (optional).

中文

试剂主要由磁珠包被物(M)、生物素标记物(R1)、吖啶酯标记物(R2)、校准品(选配)和质控品(选配)组成。

Storage conditions and expiration
English

This reagent is stored at 2~8°C and has an expiration date of 12 months. The in-machine stability of the reagent is 28 days. After the calibrator and quality control substance are reconstituted, they should be stored at 2~8 °C for 7 days, and they can be stored at -20 °C for 3 months, and the number of freeze-thaw times should not exceed 1 time.

中文

本试剂于2~8℃保存,有效期为12个月。试剂在机稳定性为28天。校准品、质控品复溶后,于2~8℃保存,有效期为7天;于-20℃下可保存3个月,冻融次数不超过1次。

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 Interleukin-12P70 Detection Kit (Chemiluminescence Immunoassay), registration 湘械注准20232400794. 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.