Apolipoprotein A2 detection reagent kit (immunoturbidimetry) - NMPA Registration 京械注准20242400025
Access comprehensive regulatory information for Apolipoprotein A2 detection reagent kit (immunoturbidimetry) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 京械注准20242400025 and owned by Beijing Enjihe Biological Engineering Co., Ltd.. The device was approved on January 16, 2024.
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For the quantitative determination of apolipoprotein A2 content in human serum in vitro.
用于体外定量测定人血清中载脂蛋白A2的含量。
Reagent 1 Tris buffer 100mmol/L,pH8.5 Reagent 2 Sheep anti-human ApoA2 antibody ＞0.15% Calibrators Phosphate buffer 20mmol/L,pH6.8 Calf serum ge; 70% Apolipoprotein A2, target concentration range: 80.0~110.0mg/dL Quality controls Phosphate buffer 20mmol/L,pH6.8 Calf serum ge; 70% Apolipoprotein A2, target range: Level 1: 10.0~50.0mg/dL Level 2: 55.0~90.0mg/dL Note: The calibrators and controls are batch-specific, and the specific concentrations are shown in the target value sheet.
试剂1 Tris缓冲液 100mmol/L，pH8.5 试剂2 羊抗人ApoA2抗体 ＞0.15% 校准品 磷酸盐缓冲液 20mmol/L，pH6.8 小牛血清 ge;70% 载脂蛋白A2，目标浓度范围： 80.0~110.0mg/dL 质控品 磷酸盐缓冲液 20mmol/L，pH6.8 小牛血清 ge;70% 载脂蛋白A2，靶值范围： 水平1：10.0~50.0mg/dL 水平2：55.0~90.0mg/dL 注：校准品及质控品具有批特异性，具体浓度见靶值单。
Store at 2°C~8°C, valid for 12 pcs
2℃～8℃保存，有效期12个