Myeloperoxidase determination reagent kit (latex immunoturbidimetric method) - NMPA Registration 京械注准20242400027
Access comprehensive regulatory information for Myeloperoxidase determination reagent kit (latex immunoturbidimetric 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 京械注准20242400027 and owned by Beijing Enjihe Biological Engineering Co., Ltd.. The device was approved on January 16, 2024.
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For in vitro quantitative determination of myeloperoxidase activity in human serum.
用于体外定量测定人血清中髓过氧化物酶的活性。
The main components of reagent 1 are: Tris buffer 100 mmol/L,pH7.0 The main components of reagent 2: Coated with anti-MPO latex particles 0.1%(W/V) The main components of the calibrator are: Phosphate buffer 80 mmol/L,pH7.4 Myeloperoxidase Level 1: 50.0~100.0ng/mL Level 2: 130.0~180.0ng/mL Level 3: 250.0~350.0ng/mL Level 4: 500.0~700.0ng/mL Level 5: 1100.0~1400.0ng/mL Key components of the control: Phosphate buffer 80 mmol/L,pH7.4 Myeloperoxidase Level 1: 50.0~150.0ng/mL Level 2: 600.0~1000 .0ng/mL Note: The calibrators and controls are batch-specific, and the specific concentrations are shown in the target value sheet.
试剂1主要组成成分： Tris缓冲液 100 mmol/L，pH7.0 试剂2主要组成成分： 包被抗MPO的胶乳颗粒 0.1%（W/V） 校准品主要组成成分： 磷酸盐缓冲液 80 mmol/L，pH7.4 髓过氧化物酶 水平1：50.0~100.0ng/mL 水平2：130.0~180 .0ng/mL 水平3：250.0~350.0ng/mL 水平4：500.0~700.0ng/mL 水平5：1100.0~1400.0ng/mL 质控品主要组成成分： 磷酸盐缓冲液 80 mmol/L，pH7.4 髓过氧化物酶 水平1：50.0~150.0ng/mL 水平2：600.0~1000 .0ng/mL 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