Warm warning: This product is not available for US market.
A. Description
This product is a multiplex fluorescent probe-based Taqman® RT-qPCR assay system.
Specific primers and probes were designed for the detection of conserved region of SARS-CoV-2’s ORF 1 ab gene and N gene, respectively.
An Internal control serves as the monitor to confirm successful extraction and identify possible PCR inhibition for the entire testing system to prevent false negative detection results.
B. Intended Use
This kit is used to achieve qualitative detection of SARS-CoV-2 viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum of suspected infected patients, suspected to have clustered cases and other patients requiring diagnosis.
C. Main Parameter
Brand | Bioteke | Model | PR2019 |
Name | Novel Coronavirus (2019－nCoV, Nucleic Acid Detection Kit (PCR) | Dimension | 60×60×65mm |
Weight | / | Storage | Cold chain for transporting and storing (-20°C) |
Package | As the picture shows | Shelf life | 12 months |
D. Kit Components
E. Product Qualification（By Dec.2nd,2022）
| Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescence PCR) 新型冠状病毒核酸检测试剂盒（荧光 PCR 法） PR2019 | |
| CE Certification – CIBG Registration Letter | CE 证书-CIBG 注册信 |
| CE Certification–EC Declaration of Conformity | CE 证书-EC 符合性声明 |
| EU COVID-19 In Vitro Diagnostic Devices and Test Methods Database | 欧盟新冠诊断试剂清单 |
| Export Qualified Suppliers | 商务部出口白名单 |
| Italy Registration | 意大利注册 |
| Bangladesh Emergency Use Authorization (EUA) | 孟加拉国紧急使用授权 |
| Peru Registration | 秘鲁注册 |
| Free sale certificate-Malaysia | 自由销售证明-马来西亚 |
| Free sale certificate-Mexico | 自由销售证明-墨西哥 |
| Free sale certificate-Indonesia | 自由销售证明-印尼 |
| Free sale certificate-Sri Lanka | 自由销售证明-斯里兰卡 |
| Free sale certificate-United Arab Emirates | 自由销售证明-阿联酋 |
| Free Sale Certificate-United States | 自由销售证明-美国 |
| Free Sale Certificate-Peru | 自由销售证明-秘鲁 |
| Free Sale Certificate-Saudi Arabia | 自由销售证明-沙特阿拉伯 |
| Free Sale Certificate-Thailand | 自由销售证明-泰国 |
| Free Sale Certificate-Vietnam | 自由销售证明-越南 |
| Free Sale Certificate-Algeria | 自由销售证明-阿尔及利亚 |
| Free Sale Certificate-Cambodia | 自由销售证明-柬埔寨 |
| Free Sale Certificate-Ghana | 自由销售证明-加纳 |
| ISO 13485 Certificate | ISO 13485 证书 |
| ISO 9001 Certificate | ISO 9001 证书 |
| ISO 45001 Certificate | ISO 45001职业健康安全管理体系认证证书 |
| ISO 14001 Certificate | ISO 14001环境管理体系认证证书 |
| IPMS Certificate | 知识产权管理体系认证证书 |
Telephone: 008651068501244