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.
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20162401135
- Approval date
- September 02, 2021
- Expiry date
- September 01, 2026
- Province/Region
- Beijing
- Address
- No. 27, Chaoqian Road, Science and Technology Park, Changping District, Beijing
- 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
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