Apo A1/Apo B 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.

• CW263

  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.
• CW011

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 28 countries total.

Trade name

Apo A1/Apo B Calibrator

UDI-DI code

16438153819216

Basic UDI-DI

6438153BU00172BX

Reference / catalog number

981921

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 Apo A1/Apo B Calibrator is used as a stock calibrator for calibration of in vitro diagnostic tests for the determination of apolipoprotein A1 and apolipoprotein B 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.

• W0102152203SPECIFIC PROTEIN STANDARDS AND CALIBRATORS

• Batch number
• Expiration date
• Manufacturing date
• Serial number
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Certificate health across this manufacturer's portfolio.