ADA

Primary DI

05204309173853

Basic UDI-DI Code

5204309000003NG

Reference

1415-0901

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class C

Status

On The Market

Manufacturer

Medicon Hellas SA

Reagent kit for In Vitro quantitative automated measurement by trained laboratory professionals of the activity of Adenosine Deaminase – ADA (EC 3.5. 4.4) in samples of human serum or pleuritic fluid from the general patient population. Measurements of ADA are to be used along with other in vitro and in vivo tests and physical examination by licensed physicians, for the investigation of pleural effusions and as an aid for diagnosis of tuberculous pleuritis. This device has not been tested for the screening, diagnosis, monitoring, management or other purposes related to ADA deficiency or deficiency of its isoenzymes. This product has been packed for use with Abbott ARCHITECT® c4000/c8000/c16000 analyzers.

The Basic UDI-DI associated with this device has 2 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 C) and regulation (EU IVDR).