Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AMD Human SARS-CoV-2 detection kit

Manufactured by Advanced Molecular Diagnostics, United Kingdom - am-diagnostics.co.uk/ 

Device identification number
19
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
LOD
1 copies/rxn
Positive control
internal positive control assay (highly conserved region of human RNA)
Analytical Specificity
100 %
Throughput
Single tubes
Notes
http://am-diagnostics.co.uk/molecular-assays/zena-max-covid-19

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