抗脱氧核糖核酸酶B检测试剂盒(胶乳免疫比浊法) - NMPA Registration 浙械注准20242402045

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.

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NMPA Official Data

Class II

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）

NMPA Registration Number: 浙械注准20242402045

DJ Fang

MedTech Regulatory Expert

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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。

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

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