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血清淀粉样蛋白A(SAA)测定试剂盒 (胶乳免疫散射比浊法) - NMPA Registration 桂械注准20242400405

Access comprehensive regulatory information for 血清淀粉样蛋白A(SAA)测定试剂盒 (胶乳免疫散射比浊法) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 桂械注准20242400405 and owned by URIT MEDICAL Electronic Co., Ltd.. The device was approved on December 06, 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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Class II
桂械注准20242400405
血清淀粉样蛋白A(SAA)测定试剂盒 (胶乳免疫散射比浊法)
血清淀粉样蛋白A(SAA)测定试剂盒 (胶乳免疫散射比浊法)
NMPA Registration Number: 桂械注准20242400405
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Intended Use
English

用于体外定量检测人全血样本中的血清淀粉样蛋白A(SAA)含量.临床上用于非特异性炎症的辅助诊断.

中文

用于体外定量检测人全血样本中的血清淀粉样蛋白A(SAA)含量。临床上用于非特异性炎症的辅助诊断。

Device Classification
Device Class
Class II
Model Specifications
型号规格:URIT SAA 12P.包装规格:试剂 3mL×1、试剂 7mL×1、试剂 14mL×1、试剂 28mL×1、试剂 28mL×2、20人份/盒(试剂 3mL×1)、50人份/盒(试剂 7mL×1)、100人份/盒(试剂 14mL×1)、200人份/盒(试剂 28mL×1)、400人份/盒(试剂 28mL×2)
型号规格:URIT SAA 12P。包装规格:试剂 3mL×1、试剂 7mL×1、试剂 14mL×1、试剂 28mL×1、试剂 28mL×2、20人份/盒(试剂 3mL×1)、50人份/盒(试剂 7mL×1)、100人份/盒(试剂 14mL×1)、200人份/盒(试剂 28mL×1)、400人份/盒(试剂 28mL×2)
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20242400405
Approval Date
December 06, 2024
Expiry Date
December 05, 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

磷酸缓冲液:2.3%、鼠抗人SAA抗体结合胶乳:0.20%、普乐净300:0.1%.

中文

磷酸缓冲液:2.3%、鼠抗人SAA抗体结合胶乳:0.20%、普乐净300:0.1%。

Storage Conditions and Expiration
English

1.储存条件:2℃~8℃避光密封存放,勿冷冻. 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℃下保存,有效期为30天.

中文

1.储存条件:2℃~8℃避光密封存放,勿冷冻。 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℃下保存,有效期为30天。

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