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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

RealBest RNA SARS-CoV-2

Manufactured by AO Vector-Best - http://www.vector-best.ru/en/ 

Device identification number
1462
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
03/24/2021 04:18
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
100 minutes
LOD
25 cpr
Positive control
Positive control for SARS-Cov-2 is included
Negative control
Negative control is included in validated NA extraction kits
Analytical Sensitivity
100 %
Analitical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 samples/run

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