DIRECT BILIRUBIN

Primary DI

05204309167333

Basic UDI-DI Code

5204309000021NJ

Reference

1415-0150

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 concentration of Direct Bilirubin in samples of human serum or plasma from the general patient population. Measurements of Direct Bilirubin are intended to be used by licensed physicians, along with other in vitro and in vivo tests and physical examination, as an aid in the investigation of conditions that may be associated with bilirubin metabolism such as jaundice, and the diagnosis and monitoring of hepatobiliary diseases. This product has been packed for use with Abbott ARCHITECT® c4000/c8000/c16000 analyzers.

The Basic UDI-DI associated with this device has 3 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).