Abnormal prothrombin assay kit (chemiluminescence)
- Device class
- Class III
- Model specifications
- 50 servings/box, 100 servings/box, 2×50 servings/box, 2×100 servings/box.50人份/盒、100人份/盒、2×50人份/盒、2×100人份/盒。
- Approval department
- State Drug Administration国家药品监督管理局
- Registration number
- 国械注准20243401590
- Approval date
- August 23, 2024
- Expiry date
- August 22, 2029
- Name
- Shanghai Kehua Bio-Engineering Co., Ltd.上海科华生物工程股份有限公司
- Province/Region
- Shanghai上海
- Address
- 1189 Qinzhou North Road, Xuhui District, Shanghai上海市徐汇区钦州北路1189号
- Production address
- 上海市徐汇区桂平路701号
This product is used for the quantitative determination of abnormal prothrombin content in human serum in vitro.
本产品用于体外定量测定人血清中异常凝血酶原的含量。
Reagent 1 (R1), Reagent 2 (R2), Reagent 3 (R3), Calibration A, Calibrated B, Control 1, Control 2. (Please refer to the manual for details)
试剂1（R1）、试剂2（R2）、试剂3（R3）、定标品A、定标品B、质控品1、质控品2。（具体内容详见说明书）
Store at 2~8 °C, no freezing, valid for 12 months.
2～8℃储存，禁止冷冻，有效期12个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for Abnormal prothrombin assay kit (chemiluminescence) 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20243401590 and owned by Shanghai Kehua Bio-Engineering Co., Ltd.. The device was approved on August 23, 2024.
This page provides complete registration details including registrant information, province location (Shanghai), 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.