HDL-LDL Calibrator

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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

• CW011

  EUDAMED did not publish a description for this code.
• CW106

  EUDAMED did not publish a description for this code.
• CW166

  EUDAMED did not publish a description for this code.
• CW263

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 28 countries total.

Trade name

HDL-LDL Calibrator

UDI-DI code

16438153816574

Basic UDI-DI

6438153BU00132BK

Reference / catalog number

981657

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 HDL/LDL Calibrator is used for calibration of in vitro diagnostic tests for the determination of HDL-Cholesterol and LDL-Cholesterol concentrations in human samples with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0101050301CALIBRATORS MULTICOMPONENT (CC)

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

Certificate health across this manufacturer's portfolio.