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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ARGENE COVID-19 R-GENE

Manufactured by bioMerieux, France - https://www.biomerieux-diagnostics.com/ 

Device identification number
2757
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Microplate
Specimen
Nasopharyngeal swab, Saliva
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
2022-12-02 09:22:17 CET
Assay Type
Unknown
Method
RT-PCR
Measurement
Qualitative
Time
90 minutes
LOD
389 cpm
Positive control
yes
Negative control
yes

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