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China NMPA legacy archive 粤械注准20252400105

Progesterone Test Kit (Magnetic Microparticle Chemiluminescence Method)

孕酮测定试剂盒(磁微粒化学发光法)
Shenzhen New Industries Biomedical Engineering Co., Ltd.Class IINMPAApproved January 21, 2025
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
30 tests/box; 50 tests/box; 100 tests/box.
30测试/盒;50测试/盒;100测试/盒。
Approval department
Guangdong Provincial Drug Administration
广东省药品监督管理局
Registration information
Registration number
粤械注准20252400105
Approval date
January 21, 2025
Expiry date
January 20, 2030
Registrant
Name
Shenzhen New Industries Biomedical Engineering Co., Ltd.
深圳市新产业生物医学工程股份有限公司
Province/Region
Guangdong
广东
Address
The 21st floor of the new industrial biology building, No. 23 Jinxiu East Road, Jinsha Community, Kengzi Street, Pingshan District, Shenzhen
深圳市坪山区坑梓街道金沙社区锦绣东路23号新产业生物大厦二十一层
Production facility
Production address
深圳市坪山区坑梓街道金沙社区锦绣东路23号
Intended use
English

本试剂盒用于体外定量测定人血清或血浆中孕酮(PROG)的含量。 临床上用于先兆流产、黄体功能不全等孕酮水平异常相关疾病的辅助诊断。

Structure and composition
English

磁性微球:包被孕酮抗体(High Five细胞重组表达)的磁性微球,PBS缓冲液;防腐剂。 低点校准品:PROG抗原(化学合成),PBS缓冲液;防腐剂。 高点校准品:PROG抗原(化学合成),PBS缓冲液;防腐剂。 缓冲液:PBS缓冲液;防腐剂。 发光标记物:ABEI标记的孕酮免疫复合物抗体(小鼠),Tris-HCl缓冲液;防腐剂。 质控品1:PROG抗原(化学合成),PBS缓冲液;防腐剂。 质控品2:PROG抗原(化学合成),PBS缓冲液;防腐剂。

Storage conditions and expiration
English

1. 货架效期 2℃~8℃保存,有效期18个月。2. 使用效期 集成试剂开封后,2℃~8℃储存有效期为6周,开封后储存时用封条封好。质控品开封后,2℃~8℃储存有效期为6周,开封后储存时应密封;10℃~30℃条件下,可稳定保存6小时;-20℃保存有效期为3个月;可冻/融次数为3次。集成试剂5℃~15℃机载有效期为4周。

Additional information
Appendix
产品技术要求、说明书
About this record

This static archive preserves historical registration fields and translations for Progesterone Test Kit (Magnetic Microparticle Chemiluminescence Method), registration 粤械注准20252400105. 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.