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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV2 Antigen Rapid Test

Manufactured by Monocent Inc., United States - www.monocent.com 

Device identification number
1320
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colorimetry
LOD
AU 1
False positives
AU 0
False negatives
% 1
Accuracy
99.25
Clinical Sensitivity
98.25 %
Type of antigen
nucleoprotein

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