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AU17011 AU17012
Bioteke
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: Prepackage (96 tests/kit).
3. Storage Conditions:24 months.
4.Prepackaged Reagents:Virus lysis buffer VL2 400ul; Buffer BB 600ul; Virus magnetic beads 10ul; Virus rinse buffer Buffer A 500ul; Rinse buffer WB 700ul; Elution buffer 80ul.
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. Applicable Instruments
This model is suitable for Biotech AU1001-96 fully automatic nucleic acid extractor and similar instruments.
D. Precautions
1. Please read the instruction manual carefully before use and operate strictly in accordance with the instructions. Clinical sample processing needs to be carried out in a clean bench or biological safety cabinet;
2. Do not mix reagents of different batches. Please use this reagent within the validity period;
3. The production date of the product is based on the actual order date of the customer to ensure the longest validity period of the reagent.
E. 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 |
F. Brochure
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: Prepackage (96 tests/kit).
3. Storage Conditions:24 months.
4.Prepackaged Reagents:Virus lysis buffer VL2 400ul; Buffer BB 600ul; Virus magnetic beads 10ul; Virus rinse buffer Buffer A 500ul; Rinse buffer WB 700ul; Elution buffer 80ul.
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. Applicable Instruments
This model is suitable for Biotech AU1001-96 fully automatic nucleic acid extractor and similar instruments.
D. Precautions
1. Please read the instruction manual carefully before use and operate strictly in accordance with the instructions. Clinical sample processing needs to be carried out in a clean bench or biological safety cabinet;
2. Do not mix reagents of different batches. Please use this reagent within the validity period;
3. The production date of the product is based on the actual order date of the customer to ensure the longest validity period of the reagent.
E. 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 |
F. Brochure
Telephone/Whatsapp: +86 18115363743
Email : zr@bioteke.cn