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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SAMBA II COVID-19 Test (near-POC NAT)

Manufactured by Diagnostics for the Real World Ltd., United States - www.drw-ltd.com/drw/about-drw.html 

Device identification number
147
CE Marking
Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
Clinical Sensitivity
98.7 %
Clinical Specificity
100 %
Notes
https://www.cam.ac.uk/research/news/rapid-covid-19-diagnostic-test-developed-by-cambridge-team-to-be-deployed-in-hospitals

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