Pregnancy-Related Plasma Protein A Assay Kit (Magnetic Particle Chemiluminescence Immunoassay)
- Device class
- Class II
- Model specifications
- 100 servings/box; 200 servings/box; Calibrator (3 levels): 3; 0.5mL,3; 1mL; Controls (2 levels): 2; 0.5mL,2; 1mL.
- Approval department
- Beijing Municipal Drug Administration
- Registration number
- 京械注准20242400542
- Approval date
- October 16, 2024
- Expiry date
- October 15, 2029
- Province/Region
- Beijing
- Address
- No. 11, Dongying Road, Zhaoquanying Town, Shunyi District, Beijing
- Production address
- 北京市顺义区赵全营镇兆丰产业基地东盈路11号
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。
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