Lipoprotein-associated phospholipase A2 assay kit (chemiluminescence magnetic particle method) - NMPA Registration 鲁械注准20242400770
Access comprehensive regulatory information for Lipoprotein-associated phospholipase A2 assay kit (chemiluminescence magnetic particle 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 鲁械注准20242400770 and owned by Shandong Kanghua Biotechnology Co., Ltd.. The device was approved on July 29, 2024.
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It is used for in vitro quantitative determination of lipoprotein-associated phospholipase A2 content in human serum samples.
用于体外定量测定人血清样本中的脂蛋白相关磷脂酶A2的含量。
Magnetic microsphere solution (R1): magnetic microspheres coated with lipoprotein-associated phospholipase A2 antibody, Tris buffer containing bovine serum albumin; Tracer conjugate (R2): acridine ester-labeled lipoprotein-associated phospholipase A2 antibody, phosphate buffered saline containing bovine serum albumin; Calibrators (C0, C1, C2): Lipoprotein-associated phospholipase A2 antigen, phosphate buffered saline containing bovine serum albumin and ProClin300 (lot specific, see reagent information card for specific concentrations); Controls (Q1, Q2): Lipoprotein-associated phospholipase A2 antigen, phosphate buffer containing bovine serum albumin and ProClin300 (lot specific, see reagent information card for specific QC ranges).
磁性微球溶液(R1):包被脂蛋白相关磷脂酶A2抗体的磁性微球,含牛血清白蛋白的Tris缓冲液; 示踪物结合物(R2):吖啶酯标记的脂蛋白相关磷脂酶A2抗体,含牛血清白蛋白的磷酸盐缓冲液; 校准品(C0、C1、C2):脂蛋白相关磷脂酶A2抗原、含牛血清白蛋白和ProClin300的磷酸盐缓冲液(批特异性,具体浓度见试剂信息卡); 质控品(Q1、Q2):脂蛋白相关磷脂酶A2抗原、含牛血清白蛋白和ProClin300的磷酸盐缓冲液(批特异性,具体质控范围见试剂信息卡)。
Store at 2~8°C, valid for 18 months.
2~8℃保存,有效期18个月。

