Total 25-hydroxyvitamin D assay kit (chemiluminescence immunoassay) - NMPA Registration 京械注准20232400529
Access comprehensive regulatory information for Total 25-hydroxyvitamin D assay kit (chemiluminescence immunoassay) 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20232400529 and owned by Beijing Diagreat Biotechnologies Co., Ltd.. The device was approved on September 01, 2023.
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It is used for in vitro quantitative determination of the content of total 25-hydroxyvitamin D in human serum or plasma.
用于体外定量测定人体血清或血浆中总25羟基维生素D的含量。
name Composition Loading Reagent M Coated with streptavidin (SA) superparamagnetic particles, > 0.1 g/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 1 Anti-total 25-hydroxyvitamin D Antibody-alkaline phosphatase marker, > 0.1 mg/L ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 2 25-OH-VD-biotin marker, > 50 ng/mL ProClin 300,0.1% Serves 50: 3mL; Serves 100: 6mL Reagent 3 Tris buffer, 50 mmol/L ProClin 300,0.1% Serves 50: 5mL; Serves 100: 10mL Calibrators (Optional) 3 levels, lyophilized with 25-hydroxyvitamin D, stabilizers, preservatives Target Concentration Range: S1:0-10 ng/mL;S2:20-40 ng/mL;S3:100-150ng/mL Reconstitute 1 mL volume Calibration information A QR code containing information about the main calibration curve / Note: Calibrator assignment is batch-specific, and the target value of each lot is detailed in the label.
名称 组成成分 装量 试剂M 包被着链霉亲和素（SA） 的超顺磁性微粒，＞0.1g/L ProClin 300，0.1% 50人份：3mL； 100人份：6mL 试剂1 抗总25羟基维生素D 抗体-碱性磷酸酶标记物，＞0.1mg/L ProClin 300，0.1% 50人份：3mL； 100人份：6mL 试剂2 25-OH-VD-生物素标记物，＞50ng/mL ProClin 300，0.1% 50人份：3mL； 100人份：6mL 试剂3 Tris缓冲液，50mmol/L ProClin 300，0.1% 50人份：5mL； 100人份：10mL 校准品 （选配） 3水平，冻干品，含25羟基维生素D， 稳定剂，防腐剂 目标浓度范围： S1：0-10 ng/mL；S2：20-40 ng/mL；S3：100-150ng/mL 复溶体积1mL 校准信息 二维码，包含主校准曲线信息 / 注：校准品赋值具有批特异性，每批次靶值详见标签。
The reagents are stored at 2 °C ~ 8 °C
试剂在2℃～8℃条件下存放有