N-atrial natriuretic peptide precursor test kit (immunochromatography) - NMPA Registration 渝械注准20202400011
Access comprehensive regulatory information for N-atrial natriuretic peptide precursor test kit (immunochromatography) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 渝械注准20202400011 and owned by Chongqing Zhongyuan BIO-TECHNOLOGY Co., Ltd.. The device was approved on October 15, 2021.
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It is used for the quantitative detection of the content of N-terminal brain natriuretic peptide precursor (NT-proBNP) in human samples (serum, plasma or whole blood) in vitro, and is mainly used clinically for the auxiliary diagnosis of heart failure.
用于体外定量检测人体样本（血清、血浆或全血）中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 consists mainly of N-terminal brain natriuretic peptide precursor detection cards. The reagent card is composed of nitrocellulose membrane, gold standard pad, sample pad, absorbent paper and plastic card, in which the gold standard pad has murine anti-human N-terminal brain natriuretic peptide precursor monoclonal labeled antibody, the quality control line (C) has sheep anti-murine IgG antibody, and the detection line (T) has mouse anti-human N-terminal brain natriuretic peptide precursor monoclonal coated antibody.
试剂盒主要由N-末端脑钠肽前体检测试剂卡组成。该试剂卡由硝酸纤维素膜、金标垫、样品垫、吸水纸和塑料卡组成，其中金标垫上有鼠抗人N-末端脑钠肽前体单克隆标记抗体，质控线（C）有羊抗鼠IgG抗体，检测线（T）有鼠抗人N-末端脑钠肽前体单克隆包被抗体。
Under the condition of aluminum foil bag sealing, 4~30 °C dry, dark environment storage, not frozen. The product is valid for 18 months.
在铝箔袋密封的条件下，4~30℃干燥、避光环境储存，不得冻存。产品有效期为18个月。