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肺炎支原体IgG抗体检测试剂盒(免疫荧光法) - NMPA Registration 国械注准20243402368

Access comprehensive regulatory information for 肺炎支原体IgG抗体检测试剂盒(免疫荧光法) 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20243402368 and owned by Qingdao Hightop Biotech Co., Ltd.. The device was approved on November 21, 2024.

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)
NMPA Registration Number: 国械注准20243402368
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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。

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.
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。
Approval Department
State Drug Administration
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
Name
Qingdao Hightop Biotech Co., Ltd.
青岛汉唐生物科技有限公司
Province/Region
Shandong
山东
Address
No. 369, Hedong Road, Qingdao High-tech Industrial Development Zone
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)
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