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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID KAVACH Anti-SARS CoV-2 Human IgG ELISA

Manufactured by Trivitron Healthcare Pvt. Ltd., India - www.trivitron.com/ 

Device identification number
1117
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
Comments
https://www.lumiradx.com/assets/pdfs/covid-19-antigen-test/sars-cov-2-ag-test-spec-sheet-ous.pdf; https://www.lumiradx.com/assets/pdfs/covid-19-antigen-test/sars-cov-2-ag-qc-product-insert-en-fr-de-it-es-se.pdf; https://www.lumiradx.com/assets/images/new/pdf/sars-cov-2-ag-qri-us-ous.pdf
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
ELISA
Measurement
Qualitative
Time
130 minutes
Detection Principle
Magnetic Electrochemical
Clinical Sensitivity
98 % IgG
Clinical Specificity
100 % IgG
Type of antigen
SARS-CoV-2 Nucleocapsid Protein (NP) antigen
Notes
Manual or automated Sandwich, Double colorimetry

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