Gastrin-17 assay kit (latex immunoturbidimetric method) - NMPA Registration 京械注准20242400450
Access comprehensive regulatory information for Gastrin-17 assay kit (latex immunoturbidimetric 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 京械注准20242400450 and owned by Beijing WantaiDerui Diagnostic Technology Co., Ltd.. The device was approved on August 27, 2024.
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It is used for in vitro quantitative determination of the content of gastrin 17 in human serum.
用于体外定量测定人血清中胃泌素17的含量。
试剂1:Tris缓冲液(pH7.0),100mmol/L. 试剂2:Tris缓冲液,50mmol/L;胃泌素17抗体,适量. 校准品:Tris缓冲液(pH7.4),胃泌素17抗原,水平1～水平5目标浓度范围分别为:0pg/mL、5pg/mL～15pg/mL、15pg/mL～25pg/mL、30pg/mL～50pg/mL、70pg/mL～90pg/mL. 质控品:Tris缓冲液(pH7.4),胃泌素17抗原,质控品靶值范围:水平1:11pg/mL～20pg/mL,水平2:25pg/mL～45pg/mL. 校准品、质控品批特异,具体浓度见瓶签.
试剂1：Tris缓冲液（pH7.0），100mmol/L。试剂2：Tris缓冲液，50mmol/L；胃泌素17抗体，适量。校准品：Tris缓冲液（pH7.4），胃泌素17抗原，水平1～水平5目标浓度范围分别为：0pg/mL、5pg/mL～15pg/mL、15pg/mL～25pg/mL、30pg/mL～50pg/mL、70pg/mL～90pg/mL。质控品：Tris缓冲液（pH7.4），胃泌素17抗原，质控品靶值范围：水平1：11pg/mL～20pg/mL，水平2：25pg/mL～45pg/mL。校准品、质控品批特异，具体浓度见瓶签。
2 °C ~ 8 °C storage, valid for 12 months.
2℃～8℃保存，有效期为12个月。