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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

RAPID TEST SARS-CoV-2 IgM/IgG GOLD

Manufactured by Technogenetics SRL, Italy - www.technogenetics.it 

Device identification number
1024
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card
Target type
Antibody, IgG, IgM
Targets
envelope protein, non-structural protein NSP3, nucleocapsid protein, ORF1a polyprotein, ORF1ab polyprotein, spike protein
Specimen
Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.testlinecd.com/file/1580/COVID-19_AN_NEW%20(002).pdf?version=202008131535 https://www.technogenetics.it/en/products-1/covid-19
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Type of antigen
Combination of selected parts of the specific antigens of SARS-CoV-2 (NCP, RBD, Spike S2, E, ACE2, PLPro protein) and antigens for exclusion cross-reactivity with other endemic coronaviruses (MERS-CoV, SARS-CoV, HCoV 229E Np, HCoV NL63 Np).

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