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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Easy SARS-CoV-2

Manufactured by Diatech Pharmacogenetics, Italy - https://www.diatechpharmacogenetics.com/en/products/ 

Device identification number
843
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
5 copies/reaction
Positive control
Positive control not specified
Negative control
Water
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 samples/run
Notes
http://sklep.genos.com.pl/zalaczniki/zalacznik1911.pdf

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