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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

LiliF GBN Covid-19 Ag Rapid kit

Manufactured by intron biotechnology, South Korea - www.intronbio.com 

Device identification number
2069
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Cassette
Target type
Antigen
Specimen
Nasopharyngeal swab
Lineages detected
B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
We got the CE-IVD already.
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunoassay
Measurement
Quantitative
Time
15 minutes
Subclass
Membrane-based
LOD
100 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
6 AU
False negatives
3 AU
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
93.6 %
Clinical Specificity
97 %
Type of antigen
Nucleoprotein

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