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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ender LAB

Manufactured by Ender diagnostics ag, Switzerland - www.enderdiagnostics.com 

Device identification number
1184
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
46 minutes
LOD
25000 copies/ml
Positive control
internal amplification control
Negative control
dH2O
Clinical Sensitivity
97.7 %
Clinical Specificity
100 %
Throughput
96 samples/run
Type of antigen
SARS-CoV-2
Notes
Isothermal Amplification

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