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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

Manufacturer website
CE Marking
yes
Detection Principle
NucleicAcid-PCR based
Format
Automated lab-based, near-POC NAT or POC NAT
Target
Nucleic Acid
Commercial Status
Commercialised
Last Update
15/07/2020
Time
60 min
Throughput
48 samples per run
Lod
300 cpm
Clinical Sensitivity
100
Clinical Specificity
100

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