Glial fibrillary acidic protein assay kit (chemiluminescence method) - NMPA Registration 川械注准20242400141
Access comprehensive regulatory information for Glial fibrillary acidic protein 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 川械注准20242400141 and owned by Sichuan Xincheng Biological Co., Ltd.. The device was approved on July 18, 2024.
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In vitro quantitative determination of the concentration of glial fibrillary acidic protein in human serum, human plasma, and human whole blood samples.
体外定量测定人血清、人血浆、人全血样本中胶质纤维酸性蛋白的浓度。
Immunomagnetic bead working solution Murine anti-human GFAP monoclonal antibody 1 5 μg/mL Magnetic beads 0.5mg/mL HEPES 50.8mmoL/L Bovine serum albumin 10g/L Enzyme conjugate working solution Alkaline phosphatase (ALP)-conjugated murine anti-human GFAP monoclonal antibody 2 0.5 μg/mL Tris(hydroxymethyl)aminomethane 50mmol/L Bovine serum albumin 10g/L Luminescent substrate solution AMPPD ≥0.05g/L Cleaning fluid Tris(hydroxymethyl)aminomethane 0.1mol/L Sample diluent Tris(hydroxymethyl)aminomethane 0.1mol/L Casein 10g/L Magnetic bead diluent HEPES 50.8mmoL/L Bovine serum albumin 10g/L Calibrators The specific concentration of glial fibrillary acidic protein is shown on the bottle label NaCl 20mmoL/L Preservative (PC300) 0.1% Quality controls The specific concentration of glial fibrillary acidic protein is shown on the bottle label NaCl 20 mmoL/L Preservative (PC300) 0.1% The assay system is traceable to the company's reference material. The components in different lot kits are not interchangeable or mixed. Note: The kit is equipped with a barcode (or QR code) of this batch, which contains reagent information such as reagent batch number, production date, and master curve information. The reagents suitable for Yingkai models need to be purchased separately from the company's following products: 1. Substrate solution for automatic immunoassay system 2. Cleaning solution
免疫磁珠工作液 鼠抗人GFAP单克隆抗体1 5μg/mL 磁珠 0.5mg/mL HEPES 50.8mmoL/L 牛血清白蛋白 10g/L 酶结合物工作液 碱性磷酸酶（ALP）标记的鼠抗人GFAP单克隆抗体2 0.5μg/mL 三羟甲基氨基甲烷 50mmol/L 牛血清白蛋白 10g/L 发光底物液 AMPPD ≥0.05g/L 清洗液 三羟甲基氨基甲烷 0.1mol/L 样本稀释液 三羟甲基氨基甲烷 0.1mol/L 酪蛋白 10g/L 磁珠稀释液 HEPES 50.8mmoL/L 牛血清白蛋白 10g/L 校准品 胶质纤维酸性蛋白 具体浓度见瓶签 NaCl 20mmoL/L 防腐剂（PC300） 0.1% 质控品 胶质纤维酸性蛋白 具体浓度见瓶签 NaCl 20 mmoL/L 防腐剂（PC300） 0.1% 测定系统可溯源至企业参考品。 不同批号试剂盒中各组分不可互换、混用。 注：试剂盒里配有本批次的条形码（或二维码），里面包含试剂批号、生产日期、主曲线信息等试剂信息。 适用于迎凯机型的试剂需单独购买本公司以下产品： 1.全自动免疫检验系统用底物液 2.清洗液
This product is stored in 2 °C ~ 8 °C closed and protected from light, and the validity period is 12 months.
本品于2℃～8℃密闭避光保存，有效期为12个月。