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China NMPA legacy archive 川械注准20242400370

Aldosterone Test Kit (Direct Chemiluminescence Method)

醛固酮测定试剂盒(直接化学发光法)
Maccura Biotechnology Co., Ltd.Class IINMPAApproved December 24, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
Device class
Class II
Model specifications
25 tests/box, 50 tests/box, 100 tests/box, 200 tests/box, 2×25 tests/box, 2×50 tests/box, 2×100 tests/box, 2×200 tests/box.
25测试/盒、50测试/盒、100测试/盒、200测试/盒、2×25测试/盒、2×50测试/盒、2×100测试/盒、2×200测试/盒。
Approval department
Sichuan Provincial Drug Administration
四川省药品监督管理局
Registration information
Registration number
川械注准20242400370
Approval date
December 24, 2024
Expiry date
December 23, 2029
Registrant
Name
Maccura Biotechnology Co., Ltd.
迈克生物股份有限公司
Province/Region
Sichuan
四川
Address
No. 16, Baichuan Road, Chengdu High-tech Zone
成都市高新区百川路16号
Production facility
Production address
成都市高新区百川路16号
Intended use
English

This product is used for the quantitative determination of the concentration of aldosterone in human serum or plasma samples in vitro.

中文

本品用于体外定量测定人血清或血浆样本中醛固酮的浓度。

Structure and composition
English

试剂盒包含试剂1(R1):磁微粒、鼠抗醛固酮单克隆抗体;试剂2(R2):吖啶酯标记的鸡抗醛固酮单克隆抗体;试剂3(R3):含HEPES的分析缓冲液;校准1(Cal1):醛固酮抗原;校准2(Cal2):醛固酮抗原.(具体内容详见产品说明书)

中文

试剂盒包含试剂1(R1):磁微粒、鼠抗醛固酮单克隆抗体;试剂2(R2):吖啶酯标记的鸡抗醛固酮单克隆抗体;试剂3(R3):含HEPES的分析缓冲液;校准1(Cal1):醛固酮抗原;校准2(Cal2):醛固酮抗原。(具体内容详见产品说明书)

Storage conditions and expiration
English

本品于2℃~8℃密闭避光保存,严禁冷冻,有效期为6个月.

中文

本品于2℃~8℃密闭避光保存,严禁冷冻,有效期为6个月。

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 Aldosterone Test Kit (Direct Chemiluminescence Method), registration 川械注准20242400370. 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.