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China NMPA legacy archive 京械注准20162401135

Cardiac Troponin I Assay Kit (Latex Immunoturbidimetric Method)

心肌肌钙蛋白I测定试剂盒(胶乳免疫比浊法)
Biosino BIO-TECHNOLOGY and Science INC.Class IINMPAApproved September 02, 2021
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
Reagent 1 (R1): 60mLtimes; 2, Reagent 2 (R2): 15mLtimes; 2; Reagent 1 (R1): 40mLtimes; 2, Reagent 2 (R2): 10mLtimes; 2; Reagent 1 (R1): 40mLtimes; 1, Reagent 2 (R2): 10mLtimes; 1; Calibrator (optional): 1mLtimes; 6 (6 concentrations); Quality control (optional): level 1:1mLtimes; 1, horizontal 2: 1mLtimes; 1.
试剂1(R1):60mLtimes;2,试剂2(R2):15mLtimes;2; 试剂1(R1):40mLtimes;2,试剂2(R2):10mLtimes;2; 试剂1(R1):40mLtimes;1,试剂2(R2):10mLtimes;1; 校准品(选配):1mLtimes;6(6个浓度); 质控品(选配):水平1:1mLtimes;1,水平2:1mLtimes;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20162401135
Approval date
September 02, 2021
Expiry date
September 01, 2026
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

It is used for the quantitative determination of human serum or plasma central troponin I (cTnI) content in vitro.

中文

用于体外定量测定人血清或血浆中心肌肌钙蛋白I(cTnI)含量。

Structure and composition
English

1. Reagent 1 (R1) (liquid) (N-Morpholine)ethanesulfonic acid (MES) buffer 100 mmol/L Reagent 2 (R2) (liquid) Anti-human cardiac troponin I antibody latex granules <0.5% 3. Calibrator (liquid) Human serum matrix, 6 concentrations, concentration range 1:0.0 micro, respectively; g/L~0.1micro; g/L, concentration 2: 0.1 micro; g/L~0.9micro; g/L, concentration 3: 0.9micro; g/L~2.0micro; g/L, concentration 4: 2.0 micro; g/L~4.5micro; g/L, concentration 5: 4.5 micro; g/L~7.5micro; g/L, concentration 6: 7.5micro; g/L~12.0micro; g/L. Each batch is valued, and the value has batch specificity, see the value list for details. 4. Controls (liquids) Human serum matrix, level 2, concentration range level 1: 0 micro; g/L~4micro; g/L, horizontal 2: 4micro; g/L~10micro; g/L. Each batch is valued, and the value has batch specificity, see the value list for details.

中文

1.试剂1(R1)(液体) (N-吗啡啉)乙磺酸(MES)缓冲液 100mmol/L 2.试剂2(R2)(液体) 抗人心肌肌钙蛋白I抗体胶乳颗粒 <0.5% 3.校准品(液体) 人血清基质,6个浓度,浓度范围分别为浓度1:0.0micro;g/L~0.1micro;g/L、浓度2:0.1micro;g/L~0.9micro;g/L、浓度3:0.9micro;g/L~2.0micro;g/L、浓度4:2.0micro;g/L~4.5micro;g/L、浓度5:4.5micro;g/L~7.5micro;g/L、浓度6:7.5micro;g/L~12.0micro;g/L。每批定值,值有批特异性,详见值单。 4. 质控品(液体) 人血清基质,2水平,浓度范围分别为水平1: 0micro;g/L~4micro;g/L、水平2:4micro;g/L~10micro;g/L。每批定值,值有批特异性,详见值单。

Storage conditions and expiration
English

2 °C ~ 8 °C stored in the dark, valid for 12 months.

中文

2℃~8℃避光贮存,有效期12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 Cardiac Troponin I Assay Kit (Latex Immunoturbidimetric Method), registration 京械注准20162401135. 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.