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骨钙素N端中分子片段检测试剂盒(化学发光微粒子免疫检测法) - NMPA Registration 浙械注准20242402088

Access comprehensive regulatory information for 骨钙素N端中分子片段检测试剂盒(化学发光微粒子免疫检测法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 浙械注准20242402088 and owned by Medicalsystem Biotechnology Co., Ltd.. The device was approved on December 24, 2024.

This page provides complete registration details including registrant information, province location (Zhejiang), 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
浙械注准20242402088
骨钙素N端中分子片段检测试剂盒(化学发光微粒子免疫检测法)
骨钙素N端中分子片段检测试剂盒(化学发光微粒子免疫检测法)
NMPA Registration Number: 浙械注准20242402088
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Intended Use
English

用于体外定量测定人血清中的骨钙素N端中分子片段(N-MID Osteocalcin)的浓度.

中文

用于体外定量测定人血清中的骨钙素N端中分子片段(N-MID Osteocalcin)的浓度。

Device Classification
Device Class
Class II
Model Specifications
50 tests/box; 100 tests/box; 200 tests/box; 400 tests/box.
50测试/盒;100测试/盒;200测试/盒;400测试/盒。
Approval Department
Zhejiang Provincial Drug Administration
浙江省药品监督管理局
Registration Information
Registration Number
浙械注准20242402088
Approval Date
December 24, 2024
Expiry Date
December 23, 2029
Registrant
Name
Medicalsystem Biotechnology Co., Ltd.
美康生物科技股份有限公司
Province/Region
Zhejiang
浙江
Address
No. 299, Qiming South Road, Yinzhou District, Ningbo
宁波市鄞州区启明南路299号
Production Facility
Production Address
宁波市鄞州区下应街道金达南路1228号
Structure and Composition
English

产品包含标记试剂、固相试剂、校准品、质控品.具体内容详见说明书.

中文

产品包含标记试剂、固相试剂、校准品、质控品。具体内容详见说明书。

Storage Conditions and Expiration
English

2~8℃保存可稳定12个月.

中文

2~8℃保存可稳定12个月。

Additional Information
Appendix
产品技术要求、说明书