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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 R-GENE (ref 432720)

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

Device identification number
526
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
LOD
380 copies/ml
Positive control
Positive control not specified
Negative control
Negative control not specified
Throughput
single tubes
Notes
https://www.biomerieux-diagnostics.com/sars-cov-2-r-gene

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