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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-COV-2 Rapid Test

Manufactured by Pharmact (Berlin), Germany - pharmact-health.com 

Device identification number
501
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card, Fingertip
Target type
Antibody
Specimen
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
20 minutes
Accuracy
99.2 % IgG
Accuracy
99 % IgM
Clinical Sensitivity
98.1 % IgM
Clinical Sensitivity
98.2 % IgG
Clinical Specificity
99.5 % IgM
Clinical Specificity
99.7 % IgG
Notes
Fingertip
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Precision
99.2 % IgG
Precision
99 % IgM
Clinical Sensitivity
98 % IgM
Clinical Sensitivity
98.2 % IgG
Clinical Specificity
99.5 % IgM
Clinical Specificity
99.7 % IgG
Notes
Card

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