Myeloperoxidase (MPO) detection kit (magnetic particle chemiluminescence method) - NMPA Registration 鲁械注准20202400835
Access comprehensive regulatory information for Myeloperoxidase (MPO) detection 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20202400835 and owned by Weifang Kanghua Biotechnology Co., Ltd. The device was approved on August 07, 2020.
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For in vitro quantitative determination of myeloperoxidase content in human serum or plasma.
用于体外定量测定人血清或血浆中的髓过氧化物酶的含量。
The kit consists of MPO calibrator C0 (0ng/mL), calibrator C1 (100ng/mL), calibrator C2 (600ng/mL), MPO control Q1 (target value 100ng/mL, target range 80~120ng/mL), control Q2 (target value 600ng/mL, target range 480~720 ng/mL), magnetic microsphere solution, tracer conjugate. The main components of the kit components are: MPO calibrators C0, C1, C2: myeloperoxidase antigen, PBS buffer containing BSA; MPO controls Q1, Q2: myeloperoxidase antigen, PBS buffer containing BSA; Magnetic bead solution: magnetic beads coated with myeloperoxidase antibodies, Tris buffer containing BSA; Tracer conjugates: acridine ester-labeled myeloperoxidase antibodies, BSA-containing PBS buffer.
该试剂盒由MPO校准品C0（0ng/mL）、校准品C1（100ng/mL）、校准品C2（600ng/mL）、MPO质控品Q1（靶值100ng/mL，靶值范围80~120ng/mL）、质控品Q2（靶值600ng/mL，靶值范围480~720 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： MPO校准品C0、C1、C2：髓过氧化物酶抗原，含BSA的PBS缓冲液； MPO质控品Q1、Q2：髓过氧化物酶抗原，含BSA的PBS缓冲液； 磁性微球溶液：包被髓过氧化物酶抗体的磁性微球，含BSA 的Tris缓冲液； 示踪物结合物：吖啶酯标记的髓过氧化物酶抗体，含BSA的PBS缓冲液。
Store at 2~8°C, valid for 12 months. Do not freeze the kit and avoid bright light. The magnetic microsphere solution is stored at 2~8 °C after opening, and the validity period is 3 months, and 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。 试剂盒禁止冷冻，避免强光照射。 磁性微球溶液开封后2~8℃存放，有效期为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。