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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

asdf

Manufactured by asdf, Bahamas - www.n.com 

Device identification number
2360
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Specimen
ACD plasma
Cross-reactivity (pathogens tested)
Adenovirus 3
Lineages detected
B.1.617.1 (Kappa), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
11
Assay Type
Immuno-Antigen
Subcategory
Sample preparation
Method
Digital-PCR
Measurement
Qualitative
Time
7 minutes
Subclass
Capture
LOD
1 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1 AU
False negatives
2 AU
Precision
Evaluated
Accuracy
1 AU
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
10 AU
Clinical Specificity
10 AU
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