Troponin I (cTnI) assay kit (magnetic particle chemiluminescence method) - NMPA Registration 鲁械注准20202401155
Access comprehensive regulatory information for Troponin I (cTnI) assay kit (magnetic particle chemiluminescence method) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 鲁械注准20202401155 and owned by Weifang Kanghua Biotechnology Co., Ltd. The device was approved on November 07, 2020.
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For in vitro quantitative determination of troponin I content in human serum or plasma.
用于体外定量测定人血清或血浆中的肌钙蛋白I的含量。
The kit consists of cTnI calibrator C0 (0ng/mL), calibrator C1 (0.10ng/mL), calibrator C2 (10.00ng/mL), cTnI control Q1 (target value 0.10ng/mL, target range 0.08~0.12ng/mL), control Q2 (target value 10.00ng/mL, target range 8.00~12.00 ng/mL), magnetic microsphere solution, tracer conjugate. The main components of the kit components are: cTnI calibrators C0, C1, C2 (lyophilized): troponin I antigen, BSA-containing PBS buffer; cTnI controls Q1, Q2 (lyophilized): troponin I antigen, BSA-containing PBS buffer; Magnetic bead solution: magnetic beads coated with troponin I antibodies, Tris buffer containing BSA; Tracer conjugates: acridine ester-labeled troponin I antibodies, BSA-containing PBS buffer.
该试剂盒由cTnI校准品C0（0ng/mL）、校准品C1（0.10ng/mL）、校准品C2（10.00ng/mL）、cTnI质控品Q1（靶值0.10ng/mL，靶值范围0.08~0.12ng/mL）、质控品Q2（靶值10.00ng/mL，靶值范围8.00~12.00 ng/mL）、磁性微球溶液、示踪物结合物组成。 试剂盒组成部分的主要组成成分为： cTnI校准品C0、C1、C2（冻干）：肌钙蛋白I抗原、含BSA的PBS缓冲液； cTnI质控品Q1、Q2（冻干）：肌钙蛋白I抗原、含BSA的PBS缓冲液； 磁性微球溶液：包被肌钙蛋白I抗体的磁性微球，含BSA 的Tris缓冲液； 示踪物结合物：吖啶酯标记的肌钙蛋白I抗体，含BSA的PBS缓冲液。
Store at 2~8°C, valid for 12 months. The magnetic microsphere solution is stored at 2~8 °C after opening, and the validity period is 3 months; After reconstitution of calibrators and quality control products, they can be aliquoted as needed and frozen at -20 °C for 3 months; Other liquid components are the same as the validity period of the finished kit. Production date, expiration date: see label.
2~8℃保存，有效期12个月。磁性微球溶液开封后2~8℃存放，有效期为3个月；校准品、质控品复溶后可根据需要分装并于-20℃冻存3个月；其他液体组分同成品试剂盒效期。生产日期、失效日期：见标签。