α1-Antitrypsin Test Kit (Immunoturbidimetric Assay) - NMPA Registration 皖械注准20222400074
Access comprehensive regulatory information for α1-Antitrypsin Test Kit (Immunoturbidimetric Assay) in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 皖械注准20222400074 and owned by Anhui Century Kangda Biotechnology Co., Ltd.. The device was approved on March 18, 2022.
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For the quantitative determination of α1-antitrypsin content in human serum in vitro.
用于体外定量测定人血清中α1-抗胰蛋白酶的含量。
R1: Phosphate buffer 50.0 mmol/L, PC300 1mL; R2: Tris buffer 50.0 mmol/L, sodium chloride 150.0mmol/L, α1-antitrypsin antibody 30.0%; The calibrator (optional) consists of bovine serum albumin and alpha-1 antitrypsin. The control low value (optional) and the control high value (optional) are composed of bovine serum albumin and α1 antitrypsin.
R1：磷酸缓冲液 50.0 mmol/L，PC300 1mL；R2 ：Tris 缓冲液 50.0 mmol/L，氯化钠 150.0mmol/L，α1-抗胰蛋白酶抗体 30.0%；校准品（选配）由牛血清白蛋白、α1-抗胰蛋白酶组成。质控品低值（选配）、质控品高值（选配）由牛血清白蛋白、α1-抗胰蛋白酶组成。
Unopened reagents should be stored at 2 °C ~ 8 °C in the dark, and the validity period is 12 months; The opened reagent was stored at 2 °C ~ 8 °C in the dark and stable for 28 days; Unopened calibrators and quality control products are sealed and protected from light at 2 °C ~ 8 °C, and the validity period is 12 months; After reconstitution of calibrators and quality control products, they are stored at 2 °C ~ 8 °C in the dark and stable for 7 days.
未开启的试剂应在2℃～8℃避光保存，有效期为12个月；开启的试剂在2℃～8℃避光保存，稳定28天；未开启的校准品、质控品在2℃～8℃密封避光保存，有效期为12个月； 校准品、质控品复溶后在2℃～8℃避光保存，稳定7天。