Bilirubin Direct

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.
• CW073

  EUDAMED did not publish a description for this code.
• CW149

  EUDAMED did not publish a description for this code.
• CW225

  EUDAMED did not publish a description for this code.

Primary placement in Finland; available across 28 countries total.

Trade name

Bilirubin Direct

UDI-DI code

16438153004391

Basic UDI-DI

6438153BU00171BV

Reference / catalog number

981909

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 direct (conjugated) bilirubin concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Bilirubin Direct test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of hyperbilirubinemia and hepatobiliary diseases, due to various acquired or inherited disorders of bilirubin metabolism, and hemolysis, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W01010203BILIRUBIN

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

Certificate health across this manufacturer's portfolio.