Bicarbonate

Primary DI

16438153818882

Basic UDI-DI Code

6438153BU00175C5

Reference

981888

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Thermo Fisher Scientific Oy

INTENDED PURPOSE / INTENDED USE For in vitro diagnostic use in the quantitative determination of bicarbonate concentration (CO2 in form of bicarbonate ions) in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Bicarbonate test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of acid-base imbalance of respiratory and metabolic systems, in patients.

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 B) and regulation (EU IVDR).