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PR2019-D、PR2020-D、PD2021-D
BioTeke
Warm warning: This product is not available for US market.
A. Description
This kit is used to achieve qualitative detection of ORF 1 ab, N gene of 2019-nCOV viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum of patients suspected to have clustered cases and other patients requiring diagnosis.
B. Intended Use
This kit is used to achieve qualitative detection of ORF1ab, N gene of 2019-nCOV viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum of suspected infected patients suspected to have clustered cases and other patients requiring diagnosis.
The kit is a fully premix lyophilized system, which includes materials needed for 2019-nCoV detection: reverse transcriptase, nucleic acid amplification enzyme, reaction buffer, specific primer and probe. RT-PCR detection can be carried out directly after adding the extracted sample RNA and and supplemented with water up to 25 μL.
C. Main Parameter
Brand | Bioteke | Model | PR2019-D |
Name | Novel Coronavirus (2019-nCoV, Nucleic Acid Detection Kit Fluorescence PCR) | Dimension | 60×60×65mm |
Weight | / | Storage | Room temperature (2-30°C) |
Package | As the picture shows | Shelf life | 12 months |
D. Advantage&Features
1、Transportation conditions: compared with normal liquid PCR detection kit, the freeze-dried product can be transported at room temperature (not more than 1 month);
2、Storage conditions: compared with normal liquid PCR detection kit which needs to be strictly stored at - 20 ± 5 ℃, the freeze-dried one can be stored at 4 ℃ for 6 months and - 20 ± 5 ℃ for at least one year;
3、Simple operation: directly add RNase-free H2O and nucleic acid to freeze-dried powder,no need of reagent preparation and sub-package.
4、Applicable equipment: ABI 7500; LightCycler 480; Bio-rad CFX96;SLAN-96S; BTK-96.
E. Kit Components
F. Comparison results
FAM: COVID-19 ORF1ab gene pseudovirus gradient dilution amplification curve
HEX:COVID-19 N gene pseudovirus gradient dilution amplification curve
Repeatability test result
G. Product Qualification(By Dec.2nd,2022)
Freeze-dried Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (Fluorescence PCR method) 冻干型新型冠状病毒(COVID-19)核酸检测试剂盒(荧光 PCR 法) PR2019-D、PR2020-D、PD2021-D | |
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 |
CE Certificate-CIBG Website notify | CE 证书-CIBG 网站公示 |
EU Website notify | 欧盟网站公示 |
Export Qualified Suppliers | 商务部出口白名单 |
Italy Registration | 意大利注册 |
Philippines special certification of COVID-19 Diagnostic Kits – PR2019-D | 菲律宾新冠诊断试剂盒特殊认证-PR2019-D |
Malaysia special access list of COVID-19 test kit – PR2020-D | 马来西亚新冠试剂盒特殊认证-PR2020-D |
Peru Registration | 秘鲁注册 |
Philippines Clinical evaluation – PR2019-D | 菲律宾临床报告-PR2019-D |
Spain Clinical evaluation – PR2019-D | 西班牙临床报告-PR2019-D |
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-Thailand | 自由销售证明书-泰国 |
Free Sale Certificate-Vietnam | 自由销售证明书-越南 |
Free Sale Certificate-Algeria | 自由销售证明书-阿尔及利亚 |
Free Sale Certificate-Cambodia | 自由销售证明书-柬埔寨 |
Free Sale Certificate-Ghana | 自由销售证明书-加纳 |
ISO 13485 Certificate | ISO 13485 证书 |
ISO 9001 Certificate | ISO 9001 证书 |
ISO 45001 Certificate | ISO45001职业健康安全管理体系认证证书 |
ISO 14001 Certificate | ISO14001环境管理体系认证证书 |
IPMS Certificate | 知识产权管理体系认证证书 |
Warm warning: This product is not available for US market.
A. Description
This kit is used to achieve qualitative detection of ORF 1 ab, N gene of 2019-nCOV viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum of patients suspected to have clustered cases and other patients requiring diagnosis.
B. Intended Use
This kit is used to achieve qualitative detection of ORF1ab, N gene of 2019-nCOV viral RNA extracted from nasopharyngeal swabs, oropharyngeal swabs and sputum of suspected infected patients suspected to have clustered cases and other patients requiring diagnosis.
The kit is a fully premix lyophilized system, which includes materials needed for 2019-nCoV detection: reverse transcriptase, nucleic acid amplification enzyme, reaction buffer, specific primer and probe. RT-PCR detection can be carried out directly after adding the extracted sample RNA and and supplemented with water up to 25 μL.
C. Main Parameter
Brand | Bioteke | Model | PR2019-D |
Name | Novel Coronavirus (2019-nCoV, Nucleic Acid Detection Kit Fluorescence PCR) | Dimension | 60×60×65mm |
Weight | / | Storage | Room temperature (2-30°C) |
Package | As the picture shows | Shelf life | 12 months |
D. Advantage&Features
1、Transportation conditions: compared with normal liquid PCR detection kit, the freeze-dried product can be transported at room temperature (not more than 1 month);
2、Storage conditions: compared with normal liquid PCR detection kit which needs to be strictly stored at - 20 ± 5 ℃, the freeze-dried one can be stored at 4 ℃ for 6 months and - 20 ± 5 ℃ for at least one year;
3、Simple operation: directly add RNase-free H2O and nucleic acid to freeze-dried powder,no need of reagent preparation and sub-package.
4、Applicable equipment: ABI 7500; LightCycler 480; Bio-rad CFX96;SLAN-96S; BTK-96.
E. Kit Components
F. Comparison results
FAM: COVID-19 ORF1ab gene pseudovirus gradient dilution amplification curve
HEX:COVID-19 N gene pseudovirus gradient dilution amplification curve
Repeatability test result
G. Product Qualification(By Dec.2nd,2022)
Freeze-dried Novel Coronavirus (COVID-19) Nucleic Acid Detection Kit (Fluorescence PCR method) 冻干型新型冠状病毒(COVID-19)核酸检测试剂盒(荧光 PCR 法) PR2019-D、PR2020-D、PD2021-D | |
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 |
CE Certificate-CIBG Website notify | CE 证书-CIBG 网站公示 |
EU Website notify | 欧盟网站公示 |
Export Qualified Suppliers | 商务部出口白名单 |
Italy Registration | 意大利注册 |
Philippines special certification of COVID-19 Diagnostic Kits – PR2019-D | 菲律宾新冠诊断试剂盒特殊认证-PR2019-D |
Malaysia special access list of COVID-19 test kit – PR2020-D | 马来西亚新冠试剂盒特殊认证-PR2020-D |
Peru Registration | 秘鲁注册 |
Philippines Clinical evaluation – PR2019-D | 菲律宾临床报告-PR2019-D |
Spain Clinical evaluation – PR2019-D | 西班牙临床报告-PR2019-D |
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-Thailand | 自由销售证明书-泰国 |
Free Sale Certificate-Vietnam | 自由销售证明书-越南 |
Free Sale Certificate-Algeria | 自由销售证明书-阿尔及利亚 |
Free Sale Certificate-Cambodia | 自由销售证明书-柬埔寨 |
Free Sale Certificate-Ghana | 自由销售证明书-加纳 |
ISO 13485 Certificate | ISO 13485 证书 |
ISO 9001 Certificate | ISO 9001 证书 |
ISO 45001 Certificate | ISO45001职业健康安全管理体系认证证书 |
ISO 14001 Certificate | ISO14001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/Whatsapp: +86 18115363743
Email : zr@bioteke.cn