| EMDDB code |
20995
|
| Basic UDI-DI |
|
| Seadme klass |
In vitro diagnostikameditsiiniseade
|
| Medical Device Nomenclature |
|
| Risk class |
IVD selftest 98/79/EC
|
| Appliance |
-
|
| Device name (in Estonian) |
Kuseteede infektsioonide testpulk
|
| Device name (in English) |
Urinary Tract Infections Test Dipstick
|
| Intended use (is Estonian) |
Kuseteede infektsioonide test (uriin) on tugevad plastikust ribad, millele on kinnitatud mitu eraldi reagendi ala. Test on mõeldud järgmiste analüütide kvalitatiivseks
tuvastamiseks uriinis: veri, valk, nitrit ja leukotsüüdid. Kuseteede infektsioonide test (uriin) on mõeldud ühekordseks kasutamiseks enesetestimisel.
|
| Intended use (in English) |
The Urinary Tract Infections Test (Urine) is firm plastic strips onto which several separate reagent areas are affixed. The test is for the qualitative detection of the
following analytes in urine: Blood, Protein, Nitrite and Leukocytes. The Urinary Tract Infections Test (Urine) is for single use in self-testing.
|
| Type/model/article number |
U031-04H
|
| Notified body |
0123
|
| Manufacturer |
Hangzhou Alltest Biotech.Co.,Ltd.
|
| Authorised representative |
MedNet EC-REP GmbH
|
| In register from |
09/03/2024
|
| Entry status |
Active
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
