Alanine aminotransferase (ALT) assay card (rate method) - NMPA Registration 湘械注准20242400880
Access comprehensive regulatory information for Alanine aminotransferase (ALT) assay card (rate 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 湘械注准20242400880 and owned by Sinocare Inc.. The device was approved on September 23, 2024.
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 detection of alanine aminotransferase (ALT) activity in human serum and plasma. Clinically, it is mainly used for the auxiliary diagnosis of liver function diseases.
用于体外定量检测人体血清、血浆中的丙氨酸氨基转移酶(ALT)的活性。临床上主要用于肝功能疾病的辅助诊断。
The product consists of a reagent card, a TIP tip (optional), and a quality control (optional). The reagent card consists of a reaction solution, a sample chamber/sample cup placement area, a dilution site, a TIP head placement area, a diluent/cleaning solution placement area, a reaction solution placement area, and a QR code (calibration curve).
产品由试剂卡、TIP 头(选配)和质控品(选配)组成。试剂卡由反应液、样本腔/样本杯放置区、稀释位、TIP头放置区、稀释液/清洗液放置区、反应液放置区及二维码(校准曲线)组成。
Reagent card: stored at 2~8 °C, valid for 12 months. Before the test, it needs to be balanced to room temperature (avoid strong light exposure), and the test should be completed within 2 hours, if it is not used for more than 2 hours, it needs to be discarded. Reagent cards that have been equilibrated to room temperature are not recyclable. Quality control: When unopened, store at 2~8 °C, expiration date of 12 months. After opening and reconstitution: store at 2~8 °C, stable for 7 days; Store at -25~-15 °C, stable for 14 days, and cannot be frozen and thawed repeatedly.
试剂卡：2～8 ℃条件下储存，有效期12个月。测试前需平衡至室温（避免强光照射），在2小时内完成测试，如超过2小时未使用，则需废弃。已平衡至室温后的试剂卡不可回收使用。质控品：未开封时，2～8 ℃条件下储存，有效期12个月。开封复溶后：2～8 ℃储存，可稳定7天；-25～-15 ℃储存，可稳定14天，不可反复冻融。