Creatine Kinase Isoenzyme (CK-MB) Detection Reagent Kit (Chemiluminescence Immunoassay) - NMPA Registration 鲁械注准20202400848
Access comprehensive regulatory information for Creatine Kinase Isoenzyme (CK-MB) Detection Reagent Kit (Chemiluminescence 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 鲁械注准20202400848 and owned by Weifang Kanghua Biotechnology Co., Ltd. The device was approved on August 12, 2020.
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.
For in vitro quantitative determination of creatine kinase isoenzyme content in human serum or plasma.
用于体外定量测定人血清或血浆中的肌酸激酶同工酶的含量。
Magnetic bead solution: magnetic beads coated with creatine kinase isoenzyme antibodies, trimethylolaminomethane buffer containing bovine serum albumin. Tracer conjugates: acridine ester-labeled creatine kinase isoenzyme antibodies, phosphate buffer containing bovine serum albumin. Calibrators C0, C1, C2 (lyophilized): creatine kinase isoenzyme antigen, calibrator diluent. Controls Q1, Q2 (lyophilized): creatine kinase isoenzyme antigen, calibrator diluent.
磁性微球溶液：包被肌酸激酶同工酶抗体的磁性微球，含牛血清白蛋白的三羟甲基氨基甲烷缓冲液。 示踪物结合物：吖啶酯标记的肌酸激酶同工酶抗体，含牛血清白蛋白的磷酸盐缓冲液。 校准品C0、C1、C2（冻干）：肌酸激酶同工酶抗原、校准品稀释液。 质控品Q1、Q2（冻干）：肌酸激酶同工酶抗原、校准品稀释液。
Store at 2~8°C, valid for 12 months.
2~8℃保存，有效期12个月。