OPTI SARS-CoV-2 Total Antibody Test Kit
Manufactured by OPTI Medical Systems, United States - www.optimedical.com
Device identification number
1422
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
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
Time
90 minutes
Detection Principle
Magnetic Electrochemical
Clinical Sensitivity
96.1 %
Clinical Specificity
98 %
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