N-terminal brain natriuretic peptide precursor (NT-proBNP) assay kit (chemiluminescence method) - NMPA Registration 粤械注准20242400382
Access comprehensive regulatory information for N-terminal brain natriuretic peptide precursor (NT-proBNP) assay kit (chemiluminescence 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 粤械注准20242400382 and owned by Aikang Diagnostics Co., Ltd.. The device was approved on March 13, 2024.
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It is used for in vitro quantitative detection of N-terminal brain natriuretic peptide precursor (NT-proBNP) in human serum, plasma and whole blood, and is mainly used for the auxiliary diagnosis of heart failure in clinical practice.
用于体外定量检测人血清、血浆、全血中 N 端脑利钠肽前体（NT-proBNP）的含量，临床上主要用于心力衰竭的辅助诊断。
It is mainly composed of magnetic particles (R1), enzyme markers (R2), calibrator 1, calibrator 2, quality control 1 (optional), and quality control 2 (optional). Magnetic particles (R1): superparamagnetic particles coated with N-terminal brain natriuretic peptide precursor antibody suspended in PBS (phosphate) buffer containing 0.05% Proclin300 (preservative); Enzyme Marker (R2): N-terminal brain natriuretic peptide precursor antibody-alkaline phosphatase marker diluted in PBS (phosphate) buffer with 0.05% Proclin300 (preservative); Calibrator 1 and Calibrator 2: NT-proBNP antigen, PBS (phosphate) buffer with 0.05% ProClin-300 (preservative); Control 1 (optional) and control 2 (optional): NT-proBNP antigen, PBS (phosphate) buffer, containing 0.05% ProClin-300 (preservative).
主要由磁微粒(R1)、酶标记物(R2)、校准品1、校准品2、质控品1（选配）、质控品2（选配）组成。 磁微粒（R1）:包被着N端脑利钠肽前体抗体的超顺磁性微粒悬浮于PBS（磷酸盐）缓冲液中，含0.05%Proclin300（防腐剂）； 酶标记物(R2):N端脑利钠肽前体抗体-碱性磷酸酶标记物稀释于PBS（磷酸盐）缓冲液中，含0.05%Proclin300（防腐剂）； 校准品1和校准品2：NT-proBNP抗原，PBS（磷酸盐）缓冲液，含0.05%ProClin-300（防腐剂）； 质控品1（选配）和质控品2（选配）：NT-proBNP抗原，PBS（磷酸盐）缓冲液，含0.05%ProClin-300（防腐剂）。
When stored in the dark at 2~8°C, the expiration date is 18 months. After opening, reagents, calibrators, and quality controls can be stored in an upright position at 2~8°C and protected from light for up to 30 days.
在 2～8℃ 环境下避光储存时，有效期为 18 个月。 试剂、校准品、质控品开封后，在 2～8℃环境下直立放置、避光储存，最长可储存 30天。