China NMPA legacy archive 国械注准20243402460IgM Antibody Test Kit for Mycoplasma Pneumoniae (Chemiluminescent Magnetic Particle Method)
肺炎支原体IgM抗体检测试剂盒（磁微粒化学发光法）
Shandong Kanghua Biotechnology Co., Ltd.Class IIINMPAApproved December 05, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- 25 servings/box, 50 servings/box, 100 servings/box, 200 servings/box.
- Approval department
- State Drug Administration
25人份/盒、50人份/盒、100人份/盒、200人份/盒。
国家药品监督管理局
Registration information
- Registration number
- 国械注准20243402460
- Approval date
- December 05, 2024
- Expiry date
- December 04, 2029
Registrant
- Province/Region
- Shandong
- Address
- No. 699, Yuehe Road, Weifang Economic Development Zone
山东
潍坊经济开发区月河路699号
Production facility
- Production address
- 潍坊经济开发区古亭街8877号
Intended use
English
本产品用于体外定性检测人血清样本或血浆样本中肺炎支原体IgM抗体.
中文
本产品用于体外定性检测人血清样本或血浆样本中肺炎支原体IgM抗体。
Structure and composition
English
磁性微球溶液、示踪物结合物、校准品C1、C2、质控品Q1、Q2、标本稀释液.(具体内容详见产品说明书)
中文
磁性微球溶液、示踪物结合物、校准品C1、C2、质控品Q1、Q2、标本稀释液。（具体内容详见产品说明书）
Storage conditions and expiration
English
Store at 2~8°C, valid for 18 months.
中文
2~8℃保存，有效期18个月。
Additional information
- Appendix
- 产品技术要求、说明书
About this record
This static archive preserves historical registration fields and translations for IgM Antibody Test Kit for Mycoplasma Pneumoniae (Chemiluminescent Magnetic Particle Method), registration 国械注准20243402460. It does not establish current authorization or complete current product details.
The default China search uses the separately verified domestic-registration listing, checked daily. Its published listing fields and scope differ from this older snapshot.