Human Elastase Inhibitor Protein (Elafin) Calibrator - NMPA Registration 粤械注准20242401235
Access comprehensive regulatory information for Human Elastase Inhibitor Protein (Elafin) Calibrator in the China medical device market through Pure Global AI's free database. This Class II medical device is registered under NMPA registration number 粤械注准20242401235 and owned by Guangzhou Darui Biotechnology Co., Ltd.. The device was approved on September 13, 2024.
This page provides complete registration details including registrant information, province location (Guangdong), 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.
Standard curve correction for the quantitative detection of human elastase inhibitory protein (Elafin) items. It is used with the human elastase inhibitory protein (Elafin) assay kit (chemiluminescence immunoassay) of Guangzhou Darui Biotechnology Co., Ltd.
用于定量检测人弹性蛋白酶抑制蛋白（Elafin）项目的标准曲线校正。 与广州市达瑞生物技术股份有限公司的人弹性蛋白酶抑制蛋白（Elafin）测定试剂盒（化学发光免疫分析法）配套使用。
Human Elastase Inhibitory Protein Calibrator 1:2 vials, each containing 1.0 mL (lyophilized reconstituted volume). Human Elastase Inhibition Protein Calibrator 2:2 vials, each vial contains 1.0 mL (lyophilized reconstituted volume). The calibrator contains the human elastase inhibitory protein antigen in Tris buffer containing a protein stabilizer.
人弹性蛋白酶抑制蛋白校准品1：2瓶，每瓶含1.0mL（冻干品复溶体积）。 人弹性蛋白酶抑制蛋白校准品2：2瓶，每瓶含1.0mL（冻干品复溶体积）。 校准品中含有人弹性蛋白酶抑制蛋白抗原，溶于含有蛋白稳定剂的Tris缓冲液中。
This calibrator must be stored at 2~8°C and must be valid for 12 months. It is recommended to store the calibrator in an upright position with the cap closed. After the calibrator is dissolved, it must be tightly capped and stored at 2~8°C for 30 days. Stored and used under specified conditions, the calibrator is stable for the expiration date.
本校准品必须在2~8℃储存，有效期12个月。建议贮藏时校准品直立放置并盖好瓶盖。 校准品在溶解后，必须盖紧瓶盖并在2~8℃储存，有效期30天。 遵循指定条件储存和使用，校准品在有效期内稳定。