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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID19 IgG/IgM Rapid Test

Manufactured by Pharmatech - https://www.phamatech.com 

Device identification number
686
CE Marking
×No
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antibody, IgG, IgM
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
04/21/2021 12:26
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Crossreactivity
Evaluated
Accuracy
92.9 % IgM
Accuracy
98.6 % IgG
Clinical Sensitivity
85 % IgM
Clinical Sensitivity
100 % IgG
Clinical Specificity
96 % IgM
Clinical Specificity
98 % IgG

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