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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ampliCube Coronavirus SARS-CoV-2

Manufactured by Mikrogen GmbH - http://www.mikrogen.de/ 

Device identification number
281
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
2021-04-06 07:44:03
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
120 minutes
LOD
1.5 copies/reaction (range: 1.5-2.2)
Positive control
Internal control
Throughput
single tubes
Notes
https://www.mikrogen.de/produkte/produktuebersicht/testsystem/coronavirus-panel.html

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