China NMPA legacy archive 国械注准20243402368肺炎支原体IgG抗体检测试剂盒(免疫荧光法)
肺炎支原体IgG抗体检测试剂盒（免疫荧光法）
Qingdao Hightop Biotech Co., Ltd.Class IIINMPAApproved November 21, 2024
Static archiveNMPA · legacy registration snapshot
Device classification
- Device class
- Class III
- Model specifications
- Card type: 1 serving/bag, 5 servings/box, 10 servings/box, 20 servings/box, 25 copies/box, 40 persons/box, 50 servings/box, 100 persons/box. Card box type: 1×24 servings/box, 2×24 servings/box, 3×24 servings/box, 4×24 servings/box, 1×25 servings/box, 2×25 servings/box, 3×25 servings/box, 4×25 servings/box, 1×48 servings/box, 2×48 servings/box, 1×50 servings/box, 2×50 servings/box.
- Approval department
- State Drug Administration
卡型：1人份/袋、5人份/盒、10人份/盒、20人份/盒、25人份/盒、40人份/盒、50人份/盒、100人份/盒。卡盒型：1×24人份/盒、2×24人份/盒、3×24人份/盒、4×24人份/盒、1×25人份/盒、2×25人份/盒、3×25人份/盒、4×25人份/盒、1×48人份/盒、2×48人份/盒、1×50人份/盒、2×50人份/盒。
国家药品监督管理局
Registration information
- Registration number
- 国械注准20243402368
- Approval date
- November 21, 2024
- Expiry date
- November 20, 2029
Registrant
- Province/Region
- Shandong
- Address
- No. 369, Hedong Road, Qingdao High-tech Industrial Development Zone
山东
青岛高新技术产业开发区河东路369号
Production facility
- Production address
- 青岛高新技术产业开发区河东路369号；潍坊经济开发区古亭街8877号（委托生产）
Intended use
English
用于体外定性检测人血清、血浆、全血样本中的肺炎支原体IgG抗体.
中文
用于体外定性检测人血清、血浆、全血样本中的肺炎支原体IgG抗体。
Structure and composition
English
试剂盒由检测卡、ID芯片组成. (具体详见说明书)
中文
试剂盒由检测卡、ID芯片组成。 （具体详见说明书）
Storage conditions and expiration
English
Store at 2~30°C, valid for 24 months.
中文
2~30℃保存，有效期24个月。
Additional information
- Remark
- 受托生产企业：山东康华生物医疗科技股份有限公司；统一社会信用代码：91370700266827355D
- Changes
- 2024-12-04 变更注册证载明的生产地址由青岛高新技术产业开发区河东路369号;变更为：青岛高新技术产业开发区河东路369号；潍坊经济开发区古亭街8877号（委托生产）
- Appendix
- 产品技术要求、说明书
About this record
This static archive preserves historical registration fields and translations for 肺炎支原体IgG抗体检测试剂盒(免疫荧光法), registration 国械注准20243402368. 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.