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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.
