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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Platelia SARS-CoV-2 Total Ab Assay

Manufactured by Bio-Rad Laboratories Inc., United States - www.bio-rad.com/ 

Device identification number
756
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Antibody
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Qualitative
Subclass
Sandwich, Double
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
86.5 % ((73-100))
Clinical Specificity
100 %
Notes
M

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