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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Logix Smart Coronavirus disease 2019 (COVID-19)

Manufactured by Co-diagnostics, United States - codiagnostics.com/ 

Device identification number
130
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
9.35 copies/μl
Positive control
positive control, proprietary blend of positive primers
Negative control
no template tube
Analytical Sensitivity
100 %
Analytical Specificity
16 microorganisms in the cross-reactivity in silico assessmenttested negative with 16 species of microorganisms100% specificity with spiked samples
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