NowCheck COVID-19 Ag Test
Manufactured by Bionote, Inc - http://bionote.co.kr/
Device identification number
1242
CE Marking
✓Yes
HSC common list
✓Yes
HSC mutual recognition
×No
Format
Near POC / POC
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
03/26/2021 11:11
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
85 TCID50/ml Range: 85-98.8
Clinical Sensitivity
89.2 %
Clinical Sensitivity
90.8 % (CT <= 33)
Clinical Specificity
97.6 %
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