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Influenza B virus IgM antibody detection kit (colloidal gold method) - NMPA Registration 国械注准20223400463

Access comprehensive regulatory information for Influenza B virus IgM antibody detection kit (colloidal gold method) 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20223400463 and owned by Weifang Kanghua Biotechnology Co., Ltd. The device was approved on April 06, 2022.

This page provides complete registration details including registrant information, province location (Shandong), 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20223400463
Influenza B virus IgM antibody detection kit (colloidal gold method)
B型流感病毒IgM抗体检测试剂盒(胶体金法)
NMPA Registration Number: 国械注准20223400463
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Pricing
Intended Use
English

For in vitro qualitative detection of influenza B virus IgM antibodies in human serum samples.

中文

用于体外定性检测人血清样本中的B型流感病毒IgM抗体。

Device Classification
Device Class
Class III
Model Specifications
20 servings/box, 30 servings/box, 40 servings/box.
20人份/盒、30人份/盒、40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20223400463
Approval Date
April 06, 2022
Expiry Date
April 05, 2027
Registrant
Name
Weifang Kanghua Biotechnology Co., Ltd
潍坊市康华生物技术有限公司
Province/Region
Shandong
山东
Address
No. 699, Yuehe Road, Weifang Economic Development Zone
潍坊经济开发区月河路699号
Production Facility
Production Address
潍坊市经济开发区月河路699号
Structure and Composition
English

Assay plates, gold standard solutions, and wash solutions. (Please refer to the manual for details)

中文

检测板、金标液和洗涤液。(具体内容详见说明书)

Additional Information
Changes
2022-05-23 “注册人名称:潍坊市康华生物技术有限公司;生产地址:潍坊市经济开发区月河路699号”变更为“注册人名称:山东康华生物医疗科技股份有限公司;生产地址:潍坊经济开发区古亭街8877号”。
Appendix
产品技术要求、说明书