Cardiac Troponin I Assay Kit (Latex Immunoturbidimetric Method)
- 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 number
- 京械注准20162401135
- Approval date
- September 02, 2021
- Expiry date
- September 01, 2026
- 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 address
- 北京市昌平区科技园区超前路27号
It is used for the quantitative determination of human serum or plasma central troponin I (cTnI) content in vitro.
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。
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.
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。
2 °C ~ 8 °C stored in the dark, valid for 12 months.
2℃～8℃避光贮存，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Cardiac Troponin I Assay Kit (Latex Immunoturbidimetric Method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20162401135 and owned by Biosino BIO-TECHNOLOGY and Science INC.. The device was approved on September 02, 2021.
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