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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Lyophilised Nucleic Acid Kit

Manufactured by AMS UK (NI) Ltd - www.amslabs.co.uk 

Device identification number
1052
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Lab-based
Target
Nucleic acid
Commercial Status
Commercialised
Last Update
03/16/2021 02:52
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
Time
60 minutes
LOD
300 cpm
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
48 samples/run

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