EMDDB code |
20858
|
Basic UDI-DI |
8437013457Promonitor004GV
|
Seadme klass |
In vitro diagnostikameditsiiniseade
|
Medical Device Nomenclature |
|
Risk class |
Class B
|
Appliance |
-
|
Device name (in Estonian) |
Promonitor-ANTI-ADL
|
Device name (in English) |
Promonitor-ANTI-ADL
|
Intended use (is Estonian) |
Promonitor-ANTI-ADL on ensüümiga seotud immunosorbentanalüüs adalimumabi vastaste antikehade kvantitatiivseks tuvastamiseks inimese seerumis.
|
Intended use (in English) |
Promonitor-ANTI-ADL is an enzyme-linked immunosorbent assay for the quantitative detection of anti-adalimumab antibodies in human serum.
|
Type/model/article number |
5090230000
|
Notified body |
0123
|
Manufacturer |
Progenika Biopharma, S.A.
|
In register from |
07/29/2024
|
Entry status |
Active
|
Reimbursed by EHIF |
Tervisekassa soodustus puudub
|