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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

New Coronavirus (COVID-19) Antigen Rapid Test

Manufactured by Anhui Formaster Biosci Co., Ltd., China - www.for-master.com 

Device identification number
2089
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual
Physical Support
Cassette
Target
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-11-03 11:14:24 CET
Comments
CE certified
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Other
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
1250 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.5 % (3 of 200)
Fn
4.848 % (8 of 165)
Precision
Evaluated
Accuracy
96.99 % ((Antigen))
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
95.15 % ((Antigen))
Clinical Specificity
98.5 % ((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