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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Human SARS-CoV-2 (Covid-19) Qualitative ELISA (manual)

Manufactured by KRISHGEN BioSystems, United States - www.krishgen.com/ 

Device identification number
253
CE Marking
×No
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
ELISA
Measurement
Qualitative
Time
120 minutes
Subclass
Sandwich
LOD
Evaluated
Precision
Evaluated

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