鲁械注准20152400612

Sperm Antibody Detection Test Kit (Enzyme-linked Immunosorbent Assay)

抗精子抗体检测试剂(酶联免疫法)
Weifang Kanghua Biotechnology Co., Ltd·Class II·NMPA·Approved October 27, 2020
Device classification
Device class
Class II
Model specifications
48 servings/box, 96 servings/box.
48人份/盒、96人份/盒。
Approval department
Shandong Provincial Drug Administration
山东省药品监督管理局
Registration information
Registration number
鲁械注准20152400612
Approval date
October 27, 2020
Expiry date
October 26, 2025
Registrant
Name
Weifang Kanghua Biotechnology Co., Ltd
潍坊市康华生物技术有限公司
Province/Region
Shandong
山东
Address
No. 699, Yuehe Road, Weifang Economic Development Zone
潍坊经济开发区月河路699号
Production facility
Production address
潍坊市经济开发区月河路699号
Intended use
English

This reagent is used for the in vitro qualitative determination of antisperm antibodies in serum.

中文

该试剂用于体外定性测定血清中的抗精子抗体。

Structure and composition
English

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 slat: antisperm antigen (ASA), carbonate buffer enzyme conjugate at pH 9.6 (liquid): anti-human-IgG monoclonal antibody, bovine serum albumin sample dilution (liquid): bovine serum concentrated wash solution (40×) (Liquid): Phosphate buffer substrate solution A (liquid): hydrogen peroxide substrate solution B (liquid): tetramethylbenzidine stop solution (liquid): sulfuric acid negative control (liquid): phosphate buffer positive control (liquid): rabbit antisperm antibody

中文

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:抗精子抗原(ASA)、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):兔抗精子抗体

Storage conditions and expiration
English

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.

中文

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。

About this record

Access comprehensive regulatory information for Sperm Antibody Detection Test 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20152400612 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.