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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AccuraTect RT-qPCR SARS-CoV-2

Manufactured by Genomictree Inc., South Korea - www.genomictree.com 

Device identification number
187
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
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
100 copies/reaction
Positive control
Internal control (human RNAse P gene)Positive control
Negative control
SARS-CoV negative control
Analytical Specificity
44 microorganisms in the cross-reactivity in silico assessmenttested negative with 35 species of microorganisms
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
single tubes

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