Pregnancy-Related Plasma Protein A Assay Kit (Magnetic Particle Chemiluminescence Immunoassay) - NMPA Registration 京械注准20242400542
Access comprehensive regulatory information for Pregnancy-Related Plasma Protein A Assay Kit (Magnetic Particle 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20242400542 and owned by Baiding Biological Engineering (Beijing) Co., Ltd.. The device was approved on October 16, 2024.
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It is used for in vitro quantitative determination of pregnancy-related plasma protein A content in human serum.
用于体外定量测定人血清中妊娠相关血浆蛋白A的含量。
Name: Main ComponentsConcentration: Reagent 1: Phosphate (PBS) buffer, immunomagnetic microspheres coated with murine pregnancy-associated plasma protein A monoclonal antibody, 0.05 mol/L, pH 7.4>0.01%, Reagent 2, phosphate (PBS) buffer, acridine ester labeled murine pregnancy-associated plasma protein A monoclonal antibody, 0.05 mol/L, pH 7.4> 10 ng/mL calibrator (liquid, 3 levels) tris-hydroxymethyl aminomethane (Tris) buffer purification of pregnancy-associated protein antigen 0.02mol/L, pH 7.4 level 1 Target concentration: 0 mIU/L level 2 Target concentration: 100 mIU/L level 3 Target concentration: 2500 mIU/L Quality control (liquid, 2 levels) Tris-hydroxymethyl aminomethane (Tris) buffer purification of pregnancy-associated protein antigen 0.02 mol/L, pH 7.4 level 1 Target concentration range: 60 mIU/ L~120mIU/L level 2 target concentration range: 1200mIU/L~2400mIU/L calibration information card QR code (containing calibration information) calibrators, quality control target values batch specific, see bottle label for details.
名称主要组分浓度试剂1磷酸盐（PBS）缓冲液包被鼠源性妊娠相关血浆蛋白A单克隆抗体的免疫磁性微球0.05mol/L，pH7.4＞0.01%试剂2磷酸盐（PBS）缓冲液吖啶酯标记的鼠源性妊娠相关血浆蛋白A单克隆抗体0.05mol/L，pH7.4＞10ng/mL校准品（液体，3水平）三羟甲基氨基甲烷（Tris）缓冲液纯化妊娠相关蛋白抗原0.02mol/L，pH7.4水平1目标浓度：0mIU/L水平2目标浓度：100mIU/L水平3目标浓度：2500mIU/L质控品（液体，2水平）三羟甲基氨基甲烷（Tris）缓冲液纯化妊娠相关蛋白抗原0.02mol/L，pH7.4水平1目标浓度范围：60mIU/L～120mIU/L水平2目标浓度范围：1200mIU/L～2400mIU/L校准信息卡二维码（内含校准信息）校准品、质控品靶值批特异，详见瓶标签。
2 °C ~ 8 °C protected from light, valid for 12 months.
2℃～8℃避光保存，有效期12个月。