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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Biocard Covid-19 Rapid Test

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

Device identification number
1116
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Antibody
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The GENEDIA W COVID-19 Ag is an in vitro diagnostic single-use test and qualitative immunoassay to detect SARS-CoV-2 antigen in nasopharyngeal swab and sputum specimen from human. This assay is designed for professional personnel in laboratory and at point-of-care as an aid in screening patients suspected of being infected and asymptomatic patients.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
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