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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-ncoV IgG/IgM Test

Manufactured by U2USystems (India) Pvt. Ltd - http://www.u2uhealth.com/ 

Device identification number
489
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Cassette
Target
Antibody
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
03/23/2021 06:59
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes

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