| EMDDB code |
21989
|
| Basic UDI-DI |
805805668CIACEN02ZZ228N82
|
| Seadme klass |
In vitro diagnostikameditsiiniseade
|
| Medical Device Nomenclature |
W0101050201 Enzyme controls
|
| Risk class |
Class B
|
| Appliance |
-
|
| Device name (in Estonian) |
ACE Control
|
| Device name (in English) |
ACE Control
|
| Intended use (is Estonian) |
ACE Control on mõeldud kasutamiseks koos ACE Reagent, et jälgida angiotensiini konverteeriva ensüümi (ACE) kineetilise määramise täpsust ja täpsust inimese seerumis või plasmas Alinity c süsteemis. Kasutage Controli materjali vastavalt näidatud analüütilisele protseduurile. In Vitro diagnostika jaoks.
Ainult professionaalsetele kasutajatele
|
| Intended use (in English) |
ACE Control is intended to be used with ACE Reagent to monitor the accuracy and precision of the kinetic determination of angiotensin converting enzyme (ACE) assay in human serum or plasma on Alinity c system. Use the Control material according to the indicated analytical procedure.
For In Vitro Diagnostic use.
For laboratory professional use only.
|
| Type/model/article number |
06U8610
|
| Notified body |
2797
|
| Manufacturer |
SENTINEL CH. S.p.A.
|
| In register from |
05/08/2025
|
| Entry status |
Active
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
