Rapid SARS-CoV-2 Antigen Test (nasopharyngeal/nasal specimen)
Manufactured by InTec PRODUCTS, INC., China - http://www.intecasi.com
Device identification number
1783
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Card, Cassette
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2021-07-23 09:54:33 CET
Comments
This product is for nasopharyngeal/nasal swab samples.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Detection Principle
Colorimetry
LOD
0.13 AU
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