Creatinine (Enzymatic)

Primary DI

16438153818455

Basic UDI-DI Code

6438153BU00130BF

Reference

981845

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 enzymatic, quantitative determination of creatinine concentration in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Creatinine test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of acute and chronic renal insufficiency, in patients. Furthermore, the Creatinine test is also indicated to be used in calculation of glomerular filtration rate (GFR) in order to evaluate kidney function in patients with chronic kidney disease (CKD) or in patients at risk of CKD. The Creatinine urine test is indicated to be used in conjunction with drug of abuse tests for identification of urine water content and a possible manipulation of a urine specimen used for drug urine screening.

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).