UltraGene Combo2Screen SARS-CoV-2 Assay
Manufactured by Advanced Biological Laboratories SA - https://www.ablsa.com/
Device identification number
764
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
03/16/2021 11:13
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
Time
105 minutes
LOD
0.000001 TCID50/ml
Analitical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
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