Creatinine (Jaffé)

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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• CW011

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• CW073

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Primary placement in Finland; available across 28 countries total.

Trade name

Creatinine (Jaffé)

UDI-DI code

16438153818103

Basic UDI-DI

6438153BU00131BH

Reference / catalog number

981810

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

INTENDED PURPOSE / INTENDED USE For in vitro diagnostic use in the quantitative determination of creatinine concentration (Jaffé reaction) in human serum, plasma and urine with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Creatinine (Jaffé) 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 (Jaffé) 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 (Jaffé) 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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010207CREATININE

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