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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgG/IgM Rapid Test (Strip)

Manufactured by CITEST DIAGNOSTICS Inc., Canada - www.citestdiagnostics.com 

Device identification number
1394
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Strip
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0
Calibration
Not evaluated
False positives
5 %
False negatives
5.6 %
Accuracy
94.9 %
Clinical Sensitivity
94.4 %
Notes
Rapid diagnostic test Strip

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