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China NMPA legacy archive 京械注准20242400542

Pregnancy-Related Plasma Protein A Assay Kit (Magnetic Particle Chemiluminescence Immunoassay)

妊娠相关血浆蛋白A测定试剂盒(磁微粒化学发光免疫分析法)
Baiding Biological Engineering (Beijing) Co., Ltd.Class IINMPAApproved October 16, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
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.
100人份/盒;200人份/盒;校准品(3水平):3;0.5mL,3;1mL;质控品(2水平):2;0.5mL,2;1mL。
Approval department
Beijing Municipal Drug Administration
北京市药品监督管理局
Registration information
Registration number
京械注准20242400542
Approval date
October 16, 2024
Expiry date
October 15, 2029
Registrant
Name
Baiding Biological Engineering (Beijing) Co., Ltd.
柏定生物工程(北京)有限公司
Province/Region
Beijing
北京
Address
No. 11, Dongying Road, Zhaoquanying Town, Shunyi District, Beijing
北京市顺义区赵全营镇兆丰产业基地东盈路11号
Production facility
Production address
北京市顺义区赵全营镇兆丰产业基地东盈路11号
Intended use
English

It is used for in vitro quantitative determination of pregnancy-related plasma protein A content in human serum.

中文

用于体外定量测定人血清中妊娠相关血浆蛋白A的含量。

Structure and composition
English

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.

中文

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。

Storage conditions and expiration
English

2 °C ~ 8 °C protected from light, valid for 12 months.

中文

2℃~8℃避光保存,有效期12个月。

About this record

This static archive preserves historical registration fields and translations for Pregnancy-Related Plasma Protein A Assay Kit (Magnetic Particle Chemiluminescence Immunoassay), registration 京械注准20242400542. It does not establish current authorization or complete current product details.

The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.