肺炎支原体IgM抗体检测试剂盒(免疫荧光法)
- 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 number
- 国械注准20243402367
- Approval date
- November 21, 2024
- Expiry date
- November 20, 2029
- 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 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）
本产品用于体外定性检测人血清、血浆、全血样本中的肺炎支原体IgM抗体.
本产品用于体外定性检测人血清、血浆、全血样本中的肺炎支原体IgM抗体。
检测卡、ID芯片.(具体内容详见说明书).
检测卡、ID芯片。（具体内容详见说明书）。
Store at 2~30°C, valid for 24 months.
2～30℃保存，有效期24个月。
- 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
Access comprehensive regulatory information for 肺炎支原体IgM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20243402367 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.