Bio-Shield 2019-nCov Total Ig
Manufactured by Prognosis Biotech, Greece - https://www.prognosis-biotech.com
Device identification number
1498
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
120 minutes
Subclass
Sandwich, Double
LOD
1 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
1 %
Precision
Evaluated
Accuracy
99.86 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 %
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