Influenza B virus IgM antibody detection kit (colloidal gold method)
- 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 number
- 国械注准20223400463
- Approval date
- April 06, 2022
- Expiry date
- April 05, 2027
- 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 address
- 潍坊市经济开发区月河路699号
For in vitro qualitative detection of influenza B virus IgM antibodies in human serum samples.
用于体外定性检测人血清样本中的B型流感病毒IgM抗体。
Assay plates, gold standard solutions, and wash solutions. (Please refer to the manual for details)
检测板、金标液和洗涤液。（具体内容详见说明书）
- 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
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.