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可溶性生长刺激表达基因2蛋白测定试剂盒(直接化学发光法) - NMPA Registration 川械注准20242400383

Access comprehensive regulatory information for 可溶性生长刺激表达基因2蛋白测定试剂盒(直接化学发光法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 川械注准20242400383 and owned by Maccura Biotechnology Co., Ltd.. The device was approved on December 25, 2024.

This page provides complete registration details including registrant information, province location (Sichuan), intended use, and regulatory compliance data from the official China NMPA medical device database. Pure Global AI offers free access to China's complete medical device registry, helping global MedTech companies navigate NMPA regulations efficiently.

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Class II
川械注准20242400383
可溶性生长刺激表达基因2蛋白测定试剂盒(直接化学发光法)
可溶性生长刺激表达基因2蛋白测定试剂盒(直接化学发光法)
NMPA Registration Number: 川械注准20242400383
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Pricing
Intended Use
English

本品用于体外定量测定人血清或血浆样本中可溶性生长刺激表达基因2蛋白的浓度.

中文

本品用于体外定量测定人血清或血浆样本中可溶性生长刺激表达基因2蛋白的浓度。

Device Classification
Device Class
Class II
Model Specifications
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. 质控品: 水平1 2.0mL×1、水平2 2.0mL×1、水平3 2.0mL×1、水平1~3 2.0mL×3.
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。 质控品: 水平1 2.0mL×1、水平2 2.0mL×1、水平3 2.0mL×1、水平1~3 2.0mL×3。
Approval Department
Sichuan Provincial Drug Administration
四川省药品监督管理局
Registration Information
Registration Number
川械注准20242400383
Approval Date
December 25, 2024
Expiry Date
December 24, 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
Structure and Composition
English

试剂盒由试剂1(R1)、试剂2(R2)、校准1(Cal1)、校准2(Cal2)、水平1(QC1)、水平2(QC2)、水平3(QC3)组成.(具体内容详见产品说明书)

中文

试剂盒由试剂1(R1)、试剂2(R2)、校准1(Cal1)、校准2(Cal2)、水平1(QC1)、水平2(QC2)、水平3(QC3)组成。(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,避免冷冻,有效期为18个月.

中文

本品于2℃~8℃密闭避光保存,避免冷冻,有效期为18个月。

Additional Information
Appendix
产品技术要求、说明书