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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

UltraGene Combo2Screen SARS-CoV-2 Assay

Manufactured by Advanced Biological Laboratories SA, Luxembourg - www.ablsa.com/ 

Device identification number
764
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
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