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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 IgM

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

Device identification number
1108
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Dotblot, Microblot
Target type
Antibody, IgM
Specimen
Plasma, Serum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.trivitron.com/uploads/brochure/15967069992Covid_Kavach_Anti-SARS_CoV-2_Human_IgG_ELISA_eBrochure.pdf https://www.testlinecd.com/microblot-array-covid-19-igm?d=231
Assay Type
Immuno-Antibody
Rapid Diagnostic
No
Reader Required
Yes
Method
Immunoassay
Measurement
Quantitative
Time
75 minutes
Clinical Sensitivity
97.72 %

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