Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CoVID-19 dtec-RT-qPCR Test

Manufactured by Genetic PCR Solutions, Spain - www.geneticpcr.com/index.php/en/ 

Device identification number
1207
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.geneticpcr.com/index.php/en/pathogen-r-d-qpcr/covid-19-rna
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
58 minutes
LOD
10 copies
Positive control
Standard template included
Negative control
DNase/RNase free water included
Analytical Sensitivity
100 % (for 10 copies)
Analytical Specificity
Analytical specificity: Tested inclusivity SARS-CoV-2 and exclusivity SARS-CoV
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
single tubes, strips or plates
Notes
https://www.geneticpcr.com/index.php/en/pathogen-r-d-qpcr/covid-19-rna

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements