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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

AndLucky COVID-19 Antigen Rapid Test

Manufactured by Zhejiang Anji Saianfu Biotech Co., Ltd, China - www.seinofy.com 

Device identification number
1296
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2021-07-07 05:26:23 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
5.75 AU
Fp
95.8 AU
Fn
99 AU
Accuracy
97.9 % (Antigen)
Clinical Sensitivity
95.8 % (Antigen)
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