Homocysteine Assay Kit (Dry Immunofluorescence Luminescence) - NMPA Registration 鲁械注准20242400802
Access comprehensive regulatory information for Homocysteine Assay Kit (Dry Immunofluorescence Luminescence) 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20242400802 and owned by Qingdao Hightop Biotech Co., Ltd.. The device was approved on August 14, 2024.
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.
It is used for in vitro quantitative determination of homocysteine (HCY) content in human serum and plasma.
用于体外定量测定人血清、血浆中同型半胱氨酸（HCY）的含量。
The kit consists of a detection plate, detection buffer (200 μL/test), and an ID chip. The test plate is composed of plastic plates and slats, and the composition of slats is PVC board, sample pad, binding pad, nitrocellulose membrane, and upper absorbent paper. The slats contain fluorescently labeled murine anti-human HCY monoclonal antibody, the detection region contains HCY-BSA-conjugated antigen, and the QC region contains goat anti-mouse IgG polyclonal antibody. The main components of the assay buffer are phosphate buffered saline (PBS), bovine serum albumin, Tween 20, and PC300. The ID chip storage information includes: basic project information, batch information, and calibration curves.
试剂盒由检测板、检测缓冲液（200μL/测试）、ID芯片组成。检测板由塑料板块和板条组成，板条的组成成分是PVC板、样品垫、结合垫、硝酸纤维素膜、上端吸水纸。其中板条包含荧光标记的鼠抗人HCY单克隆抗体、检测区包含HCY-BSA偶联抗原、质控区包含羊抗鼠IgG多克隆抗体。检测缓冲液主要成分是磷酸盐缓冲液（PBS）、牛血清白蛋白、吐温20和PC300。 ID芯片储存信息包括：项目基本信息、批次信息和校准曲线。
Store at 2~30°C, valid for 24 months.
2～30℃保存，有效期24个月。