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China NMPA legacy archive 湘械注准20232400792

Thymidine kinase 1 (TK1) cell cycle assay kit (chemiluminescence immunoassay)

胸苷激酶1(TK1)细胞周期分析检测试剂盒(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20232400792
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 reagent is used for the quantitative determination of thymidine kinase 1 content in human serum and plasma in vitro, and is clinically used to monitor tumor proliferation.

中文

本试剂用于体外定量测定人血清和血浆中胸苷激酶1的含量,临床上用于监测肿瘤增殖。

Structure and composition
English

It consists of Reagent 1, Reagent 2, Reagent M and (optional) calibrator. Reagent 1: TK1 monoclonal antibody 1 with biotin conjugate (approx. 0.2 ug/mL), phosphate buffer (with 1% bovine serum protein, 0.1% Proclin300, pH 7.4), reagent 2: TK1 monoclonal antibody with acridine ester conjugate 2 (approx. 1 ug/mL), phosphate buffer (with 1% bovine serum protein, 0.1% Proclin300, pH 7.4), reagent M: streptavidin-coated magnetic particles (approx. 0.3 mg/mL) (Optional) Calibrator: Thymidine kinase 1, phosphate buffer (1% bovine serum protein, 0.1% Proclin300, pH 7.4), concentrations of approximately 0 pmol/L, 1 pmol/L, 2 pmol/L, 5 pmol/L, 10 pmol/L, 20 pmol/L.

中文

由试剂1、试剂2、试剂M及(选配)校准品组成。试剂1:含生物素标记的TK1单克隆抗体1(约0.2ug/mL),磷酸盐缓冲液(含1%牛血清蛋白,0.1% Proclin300,pH7.4);试剂2:含吖啶酯标记的TK1单克隆抗体2(约1ug/mL),磷酸盐缓冲液(含1%牛血清蛋白,0.1% Proclin300,pH7.4);试剂M:含链霉亲和素包被的磁颗粒(约0.3mg/mL),含0.1%氯乙酰胺;(选配)校准品:含胸苷激酶1,磷酸盐缓冲液(含1%牛血清蛋白,0.1% Proclin300,pH7.4),浓度约为0pmol/L,1pmol/L,2pmol/L,5pmol/L,10pmol/L,20pmol/L。

Storage conditions and expiration
English

Store at 2-8°C, valid for 18 months; The opened reagent can be stably stored for 28 days in an environment of 2~8 °C.

中文

2-8℃环境下储存,有效期18个月;开封的试剂,2~8℃环境下可稳定保存28天。

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 Thymidine kinase 1 (TK1) cell cycle assay kit (chemiluminescence immunoassay), registration 湘械注准20232400792. 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.