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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Rapid Test (Colloidal Gold Method)

Manufactured by Hangzhou Singclean Medical Products Co., Ltd - http://www.singclean.net/ 

Device identification number
1446
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasal swab, Saliva
Commercial Status
Commercialised
Last Update
2021-04-01 10:53:32
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
4 AU ()
Calibration
evaluated
Crossreactivity
evaluated
Fp
1.44 % (98.56)
Fn
0.97 % (99.03)
Precision
evaluated
Accuracy
98.84 % ()
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
98.56 % ()
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