Prealbumin (PA) Assay Kit (Immunoturbidimetry) - NMPA Registration 湘械注准20232400820
Access comprehensive regulatory information for Prealbumin (PA) Assay Kit (Immunoturbidimetry) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 湘械注准20232400820 and owned by Hunan Yonghe-sun Biotechnology Co., Ltd.. The device was approved on August 31, 2023.
This page provides complete registration details including registrant information, province location (Hunan), 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 the concentration of PA in human serum.
用于体外定量测定人血清中PA的浓度。
Reagent 1: Tris-HCl buffer 6g/L, polyethylene glycol-6000 60g/L, Tween 20 1g/L, disodium phosphate 9g/L;Reagent 2: Tris-HCl buffer 15g/L, sodium chloride 10g/L, sodium azide 1g/L, prealbumin antibody 90g/L;calibrator concentration range: [level 1: 400mg/L-700mg/L], different amounts of PA antigen, Proclin300 1mL, BSA 10g; The concentration range of the quality control substance: [level 1: 200mg/L-500mg/L], different amounts of PA antigen, Proclin300 1mL, and BSA 10g were added.
试剂1:Tris-HCl缓冲液 6g/L、聚乙二醇-6000 60g/L、吐温20 1g/L、磷酸氢二钠 9g/L;试剂 2:Tris-HCl缓冲液 15g/L、氯化钠 10g/L、叠氮钠 1g/L、 前白蛋白抗体 90g/L;校准品浓度范围:【水平1:400mg/L-700mg/L】,添加了不同量PA抗原、Proclin300 1mL、BSA 10g;质控品浓度范围:【水平1:200mg/L-500mg/L】,添加了不同量PA抗原、Proclin300 1mL、BSA 10g。
Reagents, calibrators and quality controls should be sealed and stored at 2°C~8°C and protected from light, with a validity period of 12 months, and the reagents can be stable for 28 days at 2°C~8°C after opening the bottle, and the calibrators and quality controls can be stable for 3 days at 2°C-8°C after opening the bottle.
试剂及校准品、质控品在2℃～8℃密封避光保存，有效期12个月；已开瓶试剂注意避免污染，在 2℃～8℃下可稳定28天；校准品、质控品开瓶后2℃-8℃可稳定3天。