Cardiac Troponin I/Myoglobin/Creatine Kinase-MB Triple Determination Reagent Kit (Quantum Dot Fluorescence Immunoassay)
- Device class
- Class II
- Model specifications
- 20 servings/box, 50 servings/box
- Approval department
- Guangdong Provincial Drug Administration
- Registration number
- 粤械注准20232400549
- Approval date
- April 03, 2023
- Expiry date
- April 02, 2028
- Province/Region
- Guangdong
- Address
- 102, 602, 702, 802, 802, Shenghui Red Star Innovation Plaza, Tianliao Community, Yutang Street, Guangming District, Shenzhen
- Production address
- 广东省深圳市光明区玉塘街道田寮社区同仁路盛荟红星创智广场602、702、802
It is suitable for the quantitative detection of cardiac troponin I (cTnI), myoglobin (Myo), creatine kinase isoenzyme (CK-MB) in human serum/plasma/whole blood in vitro clinical vitro. Clinically, it is mainly used for the auxiliary diagnosis of myocardial infarction.
适用于临床体外定量检测人血清/血浆/全血中的心肌肌钙蛋白 I(cTnI)、肌红蛋白(Myo)、肌酸激酶同工酶(CK-MB)的含量。临床上主要用于心肌梗死的辅助诊断。
The kit is mainly composed of a test card, sample diluent, and IC card (optional). Thereinto: 1. The test card is composed of test strips and plastic card shells. The main components on the test strip are: marking pad, nitrocellulose membrane, absorbent paper, PVC board. The nitrocellulose membrane is coated with murine anti-human cTnI monoclonal antibody, mouse anti-human Myo monoclonal antibody, murine anti-human CK-MB monoclonal antibody and sheep anti-rabbit IgG. The labeling pad mainly contains fluorescently labeled murine anti-human cTnI monoclonal antibody, murine anti-human Myo monoclonal antibody, murine anti-human CK-MB monoclonal antibody and rabbit IgG. 2. The main components of the sample diluent are Tris buffer and surfactant.
试剂盒主要由检测卡、样本稀释液、IC卡(选配)组成。其中: 1.检测卡由试纸条、塑料卡壳组成。试纸条上的主要成分有:标记垫、硝酸纤维素膜、吸水纸、PVC板。硝酸纤维素膜包被有鼠抗人cTnI单克隆抗体、鼠抗人Myo单克隆抗体、鼠抗人CK-MB单克隆抗体和羊抗兔IgG;标记垫上主要有荧光标记的鼠抗人cTnI单克隆抗体、鼠抗人Myo单克隆抗体、鼠抗人CK-MB单克隆抗体和兔IgG。 2.样本稀释液主要成分为Tris缓冲液及表面活性剂。
The kit is stored at 2~30 °C in the dark, moisture-proof and avoid heavy pressure, and the validity period is 18 months; After the detection card foil bag is opened, it should be used as soon as possible within 1 hour under the condition of 18-28 ° C and 40-60% humidity.
试剂盒于 2~30℃避光、防潮保存并避免重压,有效期为18个月;检测卡铝箔袋开封后,在18-28℃,40-60%湿度条件下,应在1小时内尽快使用。
- Remark
- 本文件与“粤械注准20232400549”注册证共同使用。
- Changes
- 2023-04-04: 1、注册人住所由“深圳市光明区凤凰街道塘家社区光明高新区十八号路 68 号 1栋 101 及 5 楼”变更为“深圳市光明区凤凰街道塘家社区光明高新区十八号路68号1栋101及5楼(一照多址企业)”。 2、生产地址由“深圳市光明区凤凰办事处塘家社区光明高新区十八号路68号1栋5楼”变更为“广东省深圳市光明区玉塘街道田寮社区同仁路盛荟红星创智广场602、702、802”。 2023-06-15: 1、注册人住所由“深圳市光明区凤凰街道塘家社区光明高新区十八号路68号1栋101及5楼(一照多址企业)”变更为“深圳市光明区玉塘街道田寮社区同仁路盛荟红星创智广场102、602、702、802”。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for Cardiac Troponin I/Myoglobin/Creatine Kinase-MB Triple Determination Reagent Kit (Quantum Dot Fluorescence Immunoassay), registration 粤械注准20232400549. It does not establish current authorization or complete current product details.
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