| EMDDB code |
21987
|
| Basic UDI-DI |
805805668CIACEN02ZZ228N82
|
| Seadme klass |
In vitro diagnostikameditsiiniseade
|
| Medical Device Nomenclature |
W01010109 Angiotensin converting enzyme (cc)
|
| Risk class |
Class B
|
| Appliance |
-
|
| Device name (in Estonian) |
ACE Reagent
|
| Device name (in English) |
ACE Reagent
|
| Intended use (is Estonian) |
ACE Reagent on automaatne analüüs, mis on ette nähtud in vitro diagnostiliseks kasutamiseks angiotensiini konverteeriva ensüümi (ACE) aktiivsuse kvantitatiivseks määramiseks inimese seerumis või plasmas Alinity c süsteemis. Seda testi kasutatakse abivahendina kopsu sarkoidoosi ja muude kopsude ja maksahaigustega seotud patoloogiliste seisundite diagnoosimisel.
Ainult professionaalsetele kasutajatele.
|
| Intended use (in English) |
The ACE Reagent is an automated assay intended for in vitro diagnostic use in the quantitative determination of angiotensin converting enzyme (ACE) activity in human serum or plasma on the Alinity c system.
This test is used as an aid in the diagnosis of pulmonary
sarcoidosis and other pathologic conditions involving lung and liver diseases.
For laboratory professional use only.
|
| Type/model/article number |
06U8625
|
| Notified body |
2797
|
| Manufacturer |
SENTINEL CH. S.p.A.
|
| In register from |
05/08/2025
|
| Entry status |
Active
|
| Reimbursed by EHIF |
Tervisekassa soodustus puudub
|
