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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

EliGene COVID19 BASIC A RT

Manufactured by Elisabeth Pharmacon spol. s.r.o., Czechia - www.elisabeth.cz 

Device identification number
548
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
15 copies/sample
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Notes
https://www.elisabeth.cz/en/product-eligene-covid19-basic-a-rt.html

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