RealLine SARS CoV-2
Manufactured by BIORON Diagnostics GmbH, Germany - www.bioron.de
Device identification number
1460
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
100 minutes
LOD
10 cpr
Positive control
included in the kit, also internal control sample
Negative control
included in the validated NA extraction kit
Analytical Sensitivity
99 %
Analytical Specificity
99 %
Clinical Sensitivity
95 %
Clinical Specificity
95 %
Throughput
97 samples/run
Notes
https://www.bioron.de/product/rl-sars-cov-2/
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