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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Microblot-Array COVID-19 IgA

Manufactured by TestLine Clinical Diagnostics s.r.o., Czechia - www.testlinecd.com/ 

Device identification number
1106
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Automated, Manual
Physical Support
Dotblot, Microblot
Target
Antibody, IgA
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2021-05-10 01:04:00 CET
Comments
https://www.testlinecd.com/microblot-array-covid-19-iga?d=231
Assay Type
Immuno-Antibody
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
75 minutes
Subclass
Fluorescence
Clinical Sensitivity
98.28 %

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