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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Abbott RealTime SARS-CoV-2 EUA test

Manufactured by Abbott, United States - www.abbott.com/ 

Device identification number
8
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
100 copies/ml
Positive control
RNA added to each reaction, not specified
Negative control
no template tube
Analytical Sensitivity
100 % (using spiked samples)
Analitical Specificity
100 % (tested negative with 31 species of micoorganismsNPA 100% using spiked samples)
Throughput
Single tubes
Notes
https://www.fda.gov/media/136258/download

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