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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 bioMérieux SA, France - https://www.biomerieux-diagnostics.com/covid-19-r-gene 

Device identification number
2681
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Triplex PCR: SARS-CoV-2 (N gene) / SARS-CoV-2 (RdRp gene) / Endogenous internal control Complete kit: Ready-to use master mix, Enzymes, Positive control, Negative control, Endogenous internal control
Assay Type
Unknown
Method
RT-PCR
Measurement
Qualitative
LOD
380 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