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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

GenomEra SARS-CoV-2

Manufactured by Abacus Diagnostica, Finland - www.abacusdiagnostica.com/ 

Device identification number
7
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
RdRp and E genes GenomEra RUO SARS-CoV-2 test has a special approval in Finland (for research use in other countries)
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
70 minutes
Notes
https://www.abacusdiagnostica.com/products/sars-cov-2/

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