High Sensitivity Troponin I Assay Kit (Chemiluminescent Particle Immunoassay) - NMPA Registration 冀械注准20242400386
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.
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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。