ACE

Primary DI

05204309064847

Basic UDI-DI Code

5204309000002NE

Reference

1418-1160

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Medicon Hellas SA

Reagents for In Vitro quantitative automated determination of the activity of Angiotensin Converting Enzyme - ACE (EC 3.4. 15.1) in samples of human serum from the general patient population. Measurements of ACE are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, as an aid for diagnosis of sarcoidosis. This product has been packed for use with BECKMAN COULTER AU series chemistry analyzers (AU600, AU600IVD, AU400, AU640, AU2700, AU5400, AU480, and AU680). For in vitro diagnostic use only by trained laboratory professionals.

The Basic UDI-DI associated with this device has 7 devices in total. Below are some other devices sharing the same Basic UDI-DI.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).