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Calibration Product for Serum Amyloid A - NMPA Registration 桂械注准20242400401

Access comprehensive regulatory information for Calibration Product for Serum Amyloid A in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 桂械注准20242400401 and owned by URIT MEDICAL Electronic Co., Ltd.. The device was approved on December 04, 2024.

This page provides complete registration details including registrant information, province location (Guangxi), 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
桂械注准20242400401
Calibration Product for Serum Amyloid A
血清淀粉样蛋白A校准品
NMPA Registration Number: 桂械注准20242400401
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Pricing
Intended Use
English

与本公司生产的血清淀粉样蛋白A检测试剂盒配套使用,用于血清淀粉样蛋白A(SAA)检测项目的校准.

中文

与本公司生产的血清淀粉样蛋白A检测试剂盒配套使用,用于血清淀粉样蛋白A(SAA)检测项目的校准。

Device Classification
Device Class
Class II
Model Specifications
型号规格:URIT AS 12P.包装规格:a、b、c、d、e五个浓度水平:5×0.5mL;a、b、c、d、e五个浓度水平:5×1mL.
型号规格:URIT AS 12P。包装规格:a、b、c、d、e五个浓度水平:5×0.5mL;a、b、c、d、e五个浓度水平:5×1mL。
Approval Department
Guangxi Zhuang Autonomous Region Drug Administration
广西壮族自治区药品监督管理局
Registration Information
Registration Number
桂械注准20242400401
Approval Date
December 04, 2024
Expiry Date
December 03, 2029
Registrant
Name
URIT MEDICAL Electronic Co., Ltd.
桂林优利特医疗电子有限公司
Province/Region
Guangxi
广西
Address
No. D-07, Information Industrial Park, Guilin High-tech Zone
桂林市高新区信息产业园D-07号
Production Facility
Production Address
桂林市高新区信息产业园D-07号
Structure and Composition
English

本产品包含校准品a、校准品b、校准品c、校准品d、校准品e 5个浓度水平,所含主要组成成分如下: 重组人SAA蛋白(人源)0.004‰~0.2‰、磷酸缓冲液 1%、甘油 5%、普乐净300(Proclin300)0.1%.

中文

本产品包含校准品a、校准品b、校准品c、校准品d、校准品e 5个浓度水平,所含主要组成成分如下: 重组人SAA蛋白(人源)0.004‰~0.2‰、磷酸缓冲液 1%、甘油 5%、普乐净300(Proclin300)0.1%。

Storage Conditions and Expiration
English

1.储存条件:2℃~8℃避光密封存放. 2.产品有效期:未开启的产品在2℃~8℃避光密封条件下保存,有效期为12个月;已开启的产品,如未用完,应在2℃~8℃下密封保存,有效期为30天.

中文

1.储存条件:2℃~8℃避光密封存放。 2.产品有效期:未开启的产品在2℃~8℃避光密封条件下保存,有效期为12个月;已开启的产品,如未用完,应在2℃~8℃下密封保存,有效期为30天。

Additional Information
Remark
型 号:URIT AS 12P
Appendix
产品技术要求、说明书