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浙械注准20242402045

抗脱氧核糖核酸酶B检测试剂盒(胶乳免疫比浊法)

抗脱氧核糖核酸酶B检测试剂盒（胶乳免疫比浊法）
Medicalsystem Biotechnology Co., Ltd.·Class II·NMPA·Approved December 13, 2024
Device classification
Device class
Class II
Model specifications
试剂: 24mL(试剂1:1×18mL+试剂2:1×6mL); 40mL(试剂1:1×30mL+试剂2:1×10mL); 60mL(试剂1:1×45mL+试剂2:1×15mL); 80mL(试剂1:1×60mL+试剂2:1×20mL); 120mL(试剂1:2×45mL+试剂2:1×30mL); 160mL(试剂1:2×60mL+试剂2:1×40mL); 200mL(试剂1:2×75mL+试剂2:1×50mL); 240mL(试剂1:2×90mL+试剂2:1×60mL); 320mL(试剂1:4×60mL+试剂2:2×40mL); 480mL(试剂1:4×90mL+试剂2:2×60mL); 1×200测试/盒;2×200测试/盒; 1×220测试/盒;1×400测试/盒; 2×400测试/盒;1×440测试/盒; 2×440测试/盒;1×300测试/盒; 2×300测试/盒;350测试/盒;700测试/盒. 校准品(可选购):1×1mL,5×0.5mL,5×1mL,6×0.5mL,6×1mL . 质控品(可选购):1×0.5mL,1×1mL,2×0.5mL,2×1mL.
试剂: 24mL(试剂1:1×18mL+试剂2:1×6mL)； 40mL(试剂1:1×30mL+试剂2:1×10mL)； 60mL(试剂1:1×45mL+试剂2:1×15mL)； 80mL(试剂1:1×60mL+试剂2:1×20mL)； 120mL(试剂1:2×45mL+试剂2:1×30mL)； 160mL(试剂1:2×60mL+试剂2:1×40mL)； 200mL(试剂1:2×75mL+试剂2:1×50mL)； 240mL(试剂1:2×90mL+试剂2:1×60mL)； 320mL(试剂1:4×60mL+试剂2:2×40mL)； 480mL(试剂1:4×90mL+试剂2:2×60mL)； 1×200测试/盒；2×200测试/盒； 1×220测试/盒；1×400测试/盒； 2×400测试/盒；1×440测试/盒； 2×440测试/盒；1×300测试/盒； 2×300测试/盒；350测试/盒；700测试/盒。 校准品（可选购）:1×1mL,5×0.5mL,5×1mL,6×0.5mL,6×1mL 。 质控品（可选购）:1×0.5mL,1×1mL,2×0.5mL,2×1mL。
Approval department
Zhejiang Provincial Drug Administration
浙江省药品监督管理局
Registration information
Registration number
浙械注准20242402045
Approval date
December 13, 2024
Expiry date
December 12, 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
Intended use
English

用于体外定量测定人血清中抗脱氧核糖核酸酶 B的浓度.

中文

用于体外定量测定人血清中抗脱氧核糖核酸酶 B的浓度。

Structure and composition
English

产品包含试剂1、试剂2、校准品、质控品.具体内容详见说明书.

中文

产品包含试剂1、试剂2、校准品、质控品。具体内容详见说明书。

Storage conditions and expiration
English

Store at 2~8°C in the dark, valid for 12 months.

中文

2～8℃避光保存，有效期12个月。

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

Access comprehensive regulatory information for 抗脱氧核糖核酸酶B检测试剂盒(胶乳免疫比浊法) 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20242402045 and owned by Medicalsystem Biotechnology Co., Ltd.. The device was approved on December 13, 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.