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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CoviGnost AG Test Device 1x20

Manufactured by BioGnost Ltd, Croatia - www.biognost.hr 

Device identification number
2247
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual
Physical Support
Cassette
Target
Antigen
Specimen
Nasopharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-11-09 09:29:28 CET
Comments
The Contract OEM manufacturer of the Test Device is Hangzhou Alltest Biotech CO., Ltd whose COVID-19 Antigen Rapid Test (Nasopharyngeal Swab) is allready on the Common list of rapid antigen tests, as agreed by Member States (May 10. pg.10) Our CoviGnost AG Test Device is validated at Croatian Institute of Public Health with excellent validation report. We sold CoviGnost AG Test Device in Croatia, Bulgaria, Italy and Greece, without any complaint.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
0 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
2.44 % (3/123)
Fn
1.23 % (1/81)
Precision
Evaluated
Accuracy
98 %
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
96 %
Clinical Specificity
99 %

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