Apolipoprotein B

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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• CW267

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 28 countries total.

Trade name

Apolipoprotein B

UDI-DI code

16438153819308

Basic UDI-DI

6438153BU00174C3

Reference / catalog number

981930

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 apolipoprotein B (Apo B) concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Apolipoprotein B test, also in combination with the apolipoprotein A1 (Apo A1) test, is indicated to be used in conjunction with clinical evaluation for prediction of the risk for coronary heart disease and atherosclerosis, in patients. Furthermore, the Apolipoprotein B test is furthermore indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of dyslipidemia, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102010403APOLIPOPROTEIN B

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