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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 (SARS-CoV-2) Antigen Test Kit(Colloidal Gold)

Manufactured by Anhui Deep Blue Medical Technology Co., Ltd, China - www.dbluemedical.com 

Device identification number
1736
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Other
Commercial Status
Commercialised
Last Update
2021-07-07 05:19:10 CET
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Detection Principle
Colorimetry
LOD
320
Calibration
not evaluated
Crossreactivity
evaluated
Fp
2.27 % (5 of 220)
Fn
0.9 % (2 of 220)
Precision
evaluated
Accuracy
98
Reproducibility
evaluated
Robustness
not evaluated
Clinical Sensitivity
95.7
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