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幽门螺杆菌IgG抗体检测试剂(乳胶法) - NMPA Registration 国械注准20243402344

Access comprehensive regulatory information for 幽门螺杆菌IgG抗体检测试剂(乳胶法) in the China medical device market through Pure Global AI's free database. This Class III medical device is registered under NMPA registration number 国械注准20243402344 and owned by Acon Biotech (Hangzhou) Co., Ltd.. The device was approved on November 21, 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 III
国械注准20243402344
幽门螺杆菌IgG抗体检测试剂(乳胶法)
幽门螺杆菌IgG抗体检测试剂(乳胶法)
NMPA Registration Number: 国械注准20243402344
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Intended Use
English

本试剂用于体外定性检测人血清/血浆中的幽门螺杆菌IgG抗体.

中文

本试剂用于体外定性检测人血清/血浆中的幽门螺杆菌IgG抗体。

Device Classification
Device Class
Class III
Model Specifications
条型:1人份/袋,25人份/盒,50人份/盒,100人份/盒.板型:1人份/袋,1人份/盒, 5人份/盒,10人份/盒,25人份/盒,40人份/盒,100人份/盒.
条型:1人份/袋,25人份/盒,50人份/盒,100人份/盒。板型:1人份/袋,1人份/盒, 5人份/盒,10人份/盒,25人份/盒,40人份/盒,100人份/盒。
Approval Department
State Drug Administration
国家药品监督管理局
Registration Information
Registration Number
国械注准20243402344
Approval Date
November 21, 2024
Expiry Date
November 20, 2029
Registrant
Name
Acon Biotech (Hangzhou) Co., Ltd.
艾康生物技术(杭州)有限公司
Province/Region
Zhejiang
浙江
Address
No. 210, Zhenzhong Road, West Lake District, Hangzhou
杭州市西湖区振中路210号
Production Facility
Production Address
杭州市西湖区振中路210号;杭州市临安区市地街33号3幢5F、10幢(1F、4-6F)、11幢;杭州市余杭区前程路2号1幢A区、3幢1-2F A区、3-4F
Structure and Composition
English

试剂条/板(包被在硝酸纤维素膜上的鼠抗人IgG抗体和链霉亲和素,乳胶标记的幽门螺杆菌抗原和生物素)和一次性塑料吸管.(具体内容详见产品说明书)

中文

试剂条/板(包被在硝酸纤维素膜上的鼠抗人IgG抗体和链霉亲和素,乳胶标记的幽门螺杆菌抗原和生物素)和一次性塑料吸管。(具体内容详见产品说明书)

Storage Conditions and Expiration
English

产品2℃~30℃避光干燥储存,有效期24个月.

中文

产品2℃~30℃避光干燥储存,有效期24个月。

Additional Information
Changes
2024-12-05 变更注册证载明的生产地址由杭州市西湖区振中路210号;变更为:杭州市西湖区振中路210号;杭州市临安区市地街33号3幢5F、10幢(1F、4-6F)、11幢;杭州市余杭区前程路2号1幢A区、3幢1-2F A区、3-4F
Appendix
产品技术要求、说明书