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 (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 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)
Analytical 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