China NMPA legacy archive 粤械注准20232400669N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Detection 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20232400669
- Approval date
- April 19, 2023
- Expiry date
- April 18, 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 N-terminal brain natriuretic peptide precursor (NT-proBNP) in human serum/plasma/whole blood in vitro clinically, and is mainly used clinically for the auxiliary diagnosis of heart failure.
适用于临床体外定量检测人血清/血浆/全血中的N末端脑钠肽前体（NT-proBNP）的含量，临床上主要用于心力衰竭的辅助诊断。
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. Nitrocellulose membrane coated with murine anti-human NT-proBNP monoclonal antibody and sheep anti-rabbit IgG; The labeling pad mainly contains fluorescently labeled murine anti-human NT-proBNP 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NT-proBNP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NT-proBNP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 avoided 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20232400669”注册证共同使用。
- Changes
- 2023-06-16: 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“深圳市光明区玉塘街道田寮社区同仁路盛荟红星创智广场102、602、702、802”。 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”。
- Appendix
- 产品技术要求、说明书
This static archive preserves historical registration fields and translations for N-terminal Pro-brain Natriuretic Peptide (NT-proBNP) Detection Kit (Quantum Dot Fluorescence Immunoassay), registration 粤械注准20232400669. 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.