Skip to main content
European Commission logo
Live, work, travel in the EU
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

DIRECT SARS-COV-2 REALTIME PCR KIT

Manufactured by Vircell s.l., Spain - WWW.VIRCELL.COM 

Device identification number
2082
CE Marking
✓Yes
HSC common list (RAT)
×No
Target type
Nucleic acid
Lineages detected
A.23.1, AT.1, B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta),
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
all variants detected but not discriminated
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
LOD
3.5 cpr ((700 cpm))

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