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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

PRESTO 2019-nCoV Direct qPCR Kit

Manufactured by AAZ, France - www.covid19aaz.com/en/covid-19-aaz-2/ 

Device identification number
963
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
Not found Target ORF1ab; nucléocapside; https://www.oncology-and-cytogenetic-products.com/products/covid-19-detection-kit/; manufacturer webisute cannot be found at all. the info were extracted from an unzipped folder downloaded from the websited proposed by amalai
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
45 minutes
Analytical Sensitivity
6 copies/reaction

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