| MSA code |
16804
|
| Basic UDI-DI |
|
| Seadme klass |
In vitro diagnostikameditsiiniseade
|
| Medical Device Nomenclature |
|
| Risk class |
IVD selftest 98/79/EC
|
| Appliance |
-
|
| Device name (in Estonian) |
FlowFlex SARS COV-2 antigeeni kiirtest (enesetest)
|
| Device name (in English) |
FlowFlex SARS COV-2 antigent rapid test (self-testing)
|
| Intended use (is Estonian) |
Kiirtest SARS COV-2 nukleokapsiidi antigeenide tuvastamiseks nina eesosa kaape proovides.
|
| Intended use (in English) |
A rapid test for the detection of SARS-COV-2 nucleocapsid antigens in anterior nasal swab specimens.
|
| Type/model/article number |
L031-118M5, L031-118N5, L031-118W5, L031-118P5, L031-118Z5, L031-118R5
|
| Notified body |
0123
|
| Manufacturer |
Acon Biotech (Hangzhou) Co.,Ltd
|
| Authorised representative |
MedNet GmbH
|
| In register from |
08/03/2021
|
| Entry status |
Active
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
