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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CerTest SARS-CoV-2 Card test

Manufactured by CerTest Biotec, Spain - www.certest.es 

Device identification number
1173
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-05-10 01:18:20 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Detection Principle
Magnetic Electrochemical
LOD
1000 TCID50/ml
LOD
1 ng/mL
Crossreactivity
0 AU
Clinical Sensitivity
92.9 %
Clinical Specificity
99.6 %

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