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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-COV-2 RESPI R-GENE

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

Device identification number
2004
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N/A
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Measurement
Qualitative
Time
90 minutes
LOD
380 cpm
Positive control
Positive control included
Negative control
Negative control included

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