LDL-Cholesterol

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

8 warnings recorded — scroll inside the panel to see all entries.

• CW999

  P362- Take off all contaminated clothing
• CW272

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• CW011

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• CW083

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• CW159

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• CW167

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• CW306

  EUDAMED did not publish a description for this code.
• CW999

  P313 Get medical advice/ attention

Primary placement in Finland; available across 28 countries total.

Trade name

LDL-Cholesterol

UDI-DI code

16438153004766

Basic UDI-DI

6438153BU00140BJ

Reference / catalog number

981956

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

PURPOSE / INTENDED USE”: For in vitro diagnostic use in the quantitative determination of LDL-cholesterol concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The LDL-Cholesterol test is indicated to be used in conjunction with clinical evaluation for prediction and screening of the risk for coronary heart disease, atherosclerosis and hyperlipidemia, in patients. Furthermore, the LDL-Cholesterol test is indicated to be used in conjunction with clinical evaluation for monitoring of the treatment of hyperlipidemias, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010221LOW DENSITY LIPOPROTEIN CHOLESTEROL INCLUDING SD-LDL

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