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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Suresign Professional Covid-19 Antigen Rapid Test Cassette (Oral Fluid)

Manufactured by CIGA Healthcare Ltd., United Kingdom - www.cigahealthcare.com/ 

Device identification number
1976
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Specimen
Saliva
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Registered with MHRA 06 March 2021
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
2 %
False negatives
2 %
Precision
Evaluated
Accuracy
97 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
90.1 %
Clinical Specificity
99.3 %
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