Anti-endometrial antibody detection kit (enzyme-linked immunosorbent assay) - NMPA Registration 鲁械注准20152400613
Access comprehensive regulatory information for Anti-endometrial antibody detection kit (enzyme-linked immunosorbent 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 鲁械注准20152400613 and owned by Weifang Kanghua Biotechnology Co., Ltd. The device was approved on October 27, 2020.
This page provides complete registration details including registrant information, province location (Shandong), 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 the in vitro qualitative determination of anti-endometrial antibodies in serum and is suitable for clinical auxiliary diagnosis.
用于体外定性测定血清中的抗子宫内膜抗体，适用于临床辅助诊断。
The kit consists of coated slats, enzyme conjugates (liquid), specimen dilution (liquid), concentrated wash solution (40×) (liquid), substrate solution A (liquid), substrate solution B (liquid), stop solution (liquid), negative control (liquid), positive control (liquid), and sealing film. The main components of the kit components are: Coated slats: carbonate buffer against endometrial antigen (EMAb), pH 9.6 Enzyme conjugates (liquid): anti-human-IgG monoclonal antibody, bovine serum albumin Specimen dilution (liquid): bovine serum Concentrated wash solution (40×) (liquid): phosphate buffer Substrate liquid A (liquid): hydrogen peroxide Substrate liquid B (liquid): tetramethylbenzidine Stop solution (liquid): sulfuric acid Negative control (liquid): phosphate buffer Positive control (liquid): rabbit anti-endometrial antibody
试剂盒由包被板条、酶结合物（液体）、标本稀释液（液体）、浓缩洗涤液(40×)（液体）、底物液A（液体）、底物液B（液体）、终止液（液体）、阴性对照（液体）、阳性对照（液体）、封板膜组成。 试剂盒组成部分的主要组成的成分为： 包被板条：抗子宫内膜抗原（EMAb）、pH9.6的碳酸盐缓冲液 酶结合物（液体）：抗人-IgG单抗、牛血清白蛋白 标本稀释液（液体）：牛血清 浓缩洗涤液(40×)（液体）：磷酸盐缓冲液 底物液A（液体）：过氧化氢 底物液B（液体）：四甲基联苯胺 终止液（液体）：硫酸 阴性对照（液体）：磷酸盐缓冲液 阳性对照（液体）：兔抗子宫内膜抗体
The kit is stored in a dark and dry place at 2~8 °C, not frozen, and the validity period is 12 months. Opening validity period: The shelf validity period is 3 months after the slats are opened at 2~8 °C, and the other liquid components are the same as the validity period of the finished kit. The date of manufacture is shown on the label.
试剂盒于2～8℃避光、干燥处贮存，不得冻存，有效期为12个月。开封有效期：板条开封后2～8℃存放效期为3个月，其他液体组分同成品试剂盒效期。生产日期见标签。