High Sensitivity Troponin I Assay Kit (Chemiluminescent Particle Immunoassay)
- Device class
- Class II
- Model specifications
- 50 tests/box, 100 tests/box, 200 tests/box; Calibrator: 1.0mL×2 (optional); Control: 1.0mL×2 (optional);50测试/盒、100测试/盒、200测试/盒； 校准品：1.0mL×2（选配）； 质控品：1.0mL×2（选配）；
- Approval department
- Hebei Provincial Drug Administration河北省药品监督管理局
- Registration number
- 冀械注准20242400386
- Approval date
- October 10, 2024
- Expiry date
- October 09, 2029
- Name
- Hebei Archi Biological Technology Co., Ltd.河北艾驰生物科技有限公司
- Province/Region
- Hebei河北
- Address
- No. 789, Juxin Street, Eastern Area, Qian'an Economic Development Zone, Hebei Province河北迁安经济开发区东部片区聚鑫街789号
- Production address
- 河北迁安经济开发区东部片区聚鑫街789号
It is used for in vitro quantitative detection of troponin I (cTnI) content in human serum.
用于体外定量检测人体血清中肌钙蛋白I（cTnI）的含量。
M reagent: cTnI antibody-coated microparticle solids (0.5 mg/mL), stored in phosphate (50.0 mmol/L) buffer containing protein (bovine) stabilizer; Preservative. R reagent: acridine ester-labeled cTnI antibody conjugate (1.0 μg/mL), stored in phosphate (50.0 mmol/L) buffer containing protein (bovine) stabilizer; Preservative. Calibrator: Appropriate amount of cTnI stored in phosphate (50.0 mmol/L) buffer containing protein (bovine) stabilizer; Preservative. Quality Control: Appropriate amount of cTnI stored in phosphate (50.0 mmol/L) buffer containing protein (bovine) stabilizer; Preservative. Note: Both cTnI-coated antibody and cTnI-conjugated antibody are mouse monoclonal antibodies, and cTnI antigen is a recombinant antigen.
M试剂：cTnI抗体包被的微粒子固相物（0.5mg/mL），存贮于含有蛋白（牛）稳定剂的磷酸盐（50.0mmol/L）缓冲液中；防腐剂。 R试剂：吖啶酯标记的cTnI抗体结合物（1.0μg/mL），存贮于含有蛋白（牛）稳定剂的磷酸盐（50.0mmol/L）缓冲液中；防腐剂。 校准品：适量的cTnI存贮于含有蛋白（牛）稳定剂的磷酸盐（50.0mmol/L）缓冲液；防腐剂。 质控品：适量的cTnI存贮于含有蛋白（牛）稳定剂的磷酸盐（50.0mmol/L）缓冲液；防腐剂。 注cTnI包被抗体和cTnI标记抗体均为小鼠单克隆抗体，cTnI抗原为重组抗原。
Kits, calibrators, and controls are stable for 18 months when stored at 2-8°C.
试剂盒、校准品和质控品于2-8℃保存可稳定18个月。
- Appendix
- 产品技术要求、说明书
Access comprehensive regulatory information for High Sensitivity Troponin I Assay Kit (Chemiluminescent Particle Immunoassay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 冀械注准20242400386 and owned by Hebei Archi Biological Technology Co., Ltd.. The device was approved on October 10, 2024.
This page provides complete registration details including registrant information, province location (Hebei), 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.