Glutathione reductase determination reagent kit (enzyme rate method) - NMPA Registration 皖械注准20212400372
Access comprehensive regulatory information for Glutathione reductase determination reagent kit (enzyme 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 皖械注准20212400372 and owned by Anhui Century Kangda Biotechnology Co., Ltd.. The device was approved on November 08, 2021.
This page provides complete registration details including registrant information, province location (Anhui), 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 suitable for in vitro quantitative determination of glutathione reductase activity in human serum.
适用于体外定量测定人血清中的谷胱甘肽还原酶的活性。
R1 phosphate buffer 100 mmol/L oxidized glutathione 3.5 mmol/L stabilizer 50 mmol/L preservative 1% R2 phosphate buffer 100 mmol/L reduced nicotinamide adenine dinucleotide phosphate 0.20mg/L preservative 1% calibrator is lyophilized powder (optional), consisting of phosphate buffer and glutathione reductase. The low value of the control (optional) and the high value of the control (optional) are lyophilized powder, which is composed of phosphate buffer and glutathione reductase. Preservative: 1% R2 phosphate buffer 100 mmol/L reduced nicotinamide adenine dinucleotide phosphate 0.20mg/L Preservative 1% The calibrator is lyophilized powder (optional) consisting of phosphate buffer and glutathione reductase. The low value of the control (optional) and the high value of the control (optional) are lyophilized powder, which is composed of phosphate buffer and glutathione reductase.
R1 磷酸盐缓冲液 100 mmol/L氧化型谷胱甘肽 3.5 mmol/L稳定剂 50 mmol/L防腐剂 1%R2 磷酸盐缓冲液 100 mmol/L还原型烟酰胺腺嘌呤二核苷酸磷酸 0.20mg/L防腐剂 1%校准品为冻干粉（选配）由磷酸盐缓冲液、谷胱甘肽还原酶组成。质控品低值（选配）、质控品高值（选配）为冻干粉由磷酸盐缓冲液、谷胱甘肽还原酶组成。防腐剂 1% R2 磷酸盐缓冲液 100 mmol/L 还原型烟酰胺腺嘌呤二核苷酸磷酸 0.20mg/L 防腐剂 1% 校准品为冻干粉（选配）由磷酸盐缓冲液、谷胱甘肽还原酶组成。质控品低值（选配）、质控品高值（选配）为冻干粉由磷酸盐缓冲液、谷胱甘肽还原酶组成。
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 stored at 2 °C ~ 8 °C in the dark, 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 5 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5天。