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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

FluoroType® SARS-CoV-2 evo

Manufactured by Hain Lifescience a Bruker company, Germany - https://www.bruker.com 

Device identification number
2972
CE Marking
×No
HSC common list (RAT)
×No
Format
Semi-automated
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
Please contact us for further information.
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Measurement
Qualitative
Time
120 minutes
Positive control
C+ provided with the kit
Notes
This assay detects the SARS-CoV-2 target RdRP and important SARS-CoV-2 mutations on the spike gene (K417T, K417N, E484Q, P681R)

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