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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Anti-SARS-Cov-2 ELISA IgG

Manufactured by Immunostep S.L, Spain - www.immunostep.com/ 

Device identification number
1657
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody, IgG
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
120 minutes
LOD
0
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
See technical Data Sheet
False negatives
See technical Data Sheet
Precision
Evaluated
Accuracy
See technical Data Sheet
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
See technical Data Sheet
Notes
Manual or automated fluorescence

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