COVID-19 In Vitro Diagnostic Medical Device – CLINITEST Rapid Covid-19 Antigen Test

Manufactured by Siemens Healthineers, Germany

Device identification number 1218
CE Marking Yes
HSC common list Yes
HSC mutual recognition Yes
Format Near POC / POC
Physical Support Cassette
Target Antigen
Specimen Nasal swab, Nasopharyngeal swab
Commercial Status Commercialised
Assay Type Immuno-Antigen
Rapid Diagnostic Yes
Reader Required No
Method Immunochromatography
Measurement Quantitative
Time 15 minutes
Detection Principle  Colloidal gold
Clinical Sensitivity 95.06 %
Clinical Specificity 99.62 %

 

The European Commission’s 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.

 

 

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