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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

LUCA NK COVID-19 Ag NP LLB

Manufactured by LUCA AICELL Inc., South Korea - http://lucaaicell.com/ 

Device identification number
2670
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Registration Number(at the German CA/DIMDI)DE/CA70/40838 : 166347
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
2 ng/mL (Nucleocapcid protein recombinant antigen)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
3 %
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
95 % (Antigen)
Clinical Specificity
100 % (Antigen)
Type of antigen
Nucleocapsid protein

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