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China NMPA legacy archive 国械注准20253400108

Mycoplasma pneumoniae IgM antibody detection test kit (magnetic microparticle chemiluminescence method)

肺炎衣原体IgM抗体检测试剂盒（磁微粒化学发光法）
Shandong Kanghua Biotechnology Co., Ltd.Class IIINMPAApproved January 10, 2025
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.
25人份/盒、50人份/盒、100人份/盒、200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20253400108
Approval date
January 10, 2025
Expiry date
January 09, 2030
Registrant
Name
Shandong Kanghua Biotechnology Co., Ltd.
山东康华生物医疗科技股份有限公司
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衣原体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 Mycoplasma pneumoniae IgM antibody detection test kit (magnetic microparticle chemiluminescence method), registration 国械注准20253400108. 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.