Bio-Shield 2019-nCov Total Ig
Manufactured by Prognosis Biotech - https://www.prognosis-biotech.com/
Device identification number
1498
CE Marking
✓Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Target
Antibody
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2021-03-25 05:55:09
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Time
120 minutes
Subclass
Sandwich, Double
LOD
1 AU ()
Calibration
evaluated
Crossreactivity
evaluated
Fp
0 %
Fn
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