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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Lyra SARS-CoV-2 Assay

Manufactured by Quidel Coorporation, United States - www.quidel.com 

Device identification number
331
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
Comments
Additional info at https://www.quidel.com/sites/default/files/product/documents/PI_Lyra_SARS-CoV-2_04-06-20.pdf
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
75 minutes
Positive control
Positive Control #M5153. Process control.
Negative control
Negative Control #M5031
Analytical Sensitivity
Evaluated
Analytical Specificity
Evaluated
Throughput
single tubes
Notes
https://www.quidel.com/molecular-diagnostics/lyra-sars-cov-2-assay

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