Warm warning: This product is not available for US market.
A. Description
1 . Isolation and purification of high quality viral DNA/ RNA from serum plasma, swab preservation solution or various virus presevervation solutions;
2. Package: bottled reagents (200 tests per kit) or prepackage (96 tests per kit);
3. Proteinase K: 4-25℃for short term, -70 C for long-term storage magnetic bead: 1 0-25℃；Other: room temperature.
B.Intended Use
For isolation and purification of high-quality viral DNA / RNA from serum, plasma, swab preservation solution or various virus preservation solutions. Only available for lab on IVD application.
C. Main Parameter
Brand | Bioteke | Model | AU52012 AU17011 AU17012 |
Name | Nucleic Acid Extraction Kit | Dimension | 20*18*15cm(in bulk） 16.5*12.5*11.5cm(prepackaged） |
Weight | / | Storage | As the description shows |
Package | As the description shows | Shelf life | 12 months |
D. Product Qualifications（By Dec.6th,2022）
| Nucleic Acid Extraction Kit 核酸提取试剂 AU18112, AU4001, AU19014, AU1201, AU70011, AU7011, AU31111, AU46111, AU52012, AU17011, AU10111, DP1801, DP1802, DP1901, DP1902, DP4611, DP4612, DP4613, DP3111, DP3112, DP3113, DP3114, RP5401, RP5402, AU17012 | |
| CE Certification – CIBG Registration Letter | CE 证书-CIBG 注册信 |
| CE Certification –CIBG Registration Prove | CE 证书-CIBG 网站注册证明 |
| CE Certification–EC Declaration of Conformity | CE 证书-EC 符合性声明 |
| CE Certification – CIBG Registration Letter-AU52111 | CE 证书-CIBG 注册信-AU52111 |
| CE Certification –CIBG Registration Prove-AU52111 | CE 证书-CIBG 网站注册证明-AU52111 |
| CE Certification–EC Declaration of Conformity-AU52111 | CE 证书-EC 符合性声明-AU52111 |
| MHRA Registration | 英国 MHRA 注册 |
| MHRA Registration- UKCA Declaration of Conformity | 英国 MHRA 注册-UKCA 符合性声明 |
| NQA Compliance Report | NQA 评审报告 |
| FDA Registration | FDA 注册 |
| CFDA(NMPA) Registration | CFDA(NMPA) 注册 |
| Italy Registration | 意大利注册 |
| Australian Register of Therapeutic Goods Certificate | 澳大利亚注册 |
| Brazil ANVISA Registration-DP46XX | 巴西注册-DP46XX |
| Brazil ANVISA Registration-AU17011 | 巴西注册-AU17011 |
| Indonesia Registration | 印度尼西亚注册 |
| Peru Registration | 秘鲁注册 |
| New Zealand Registration | 新西兰注册 |
| EN11737 test report-Prepackaged consumables | EN11737 检验报告-预封装耗材 |
| Free sale certificate-United Arab Emirates | 自由销售证明-阿联酋 |
| Free sale certificate-Saudi Arabia | 自由销售证明-沙特阿拉伯 |
| 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 |
| Certificate for Exportation of Medical Products | 出口销售证明 |
| 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 |
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