Immunoglobulin M

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

Immunoglobulin M

UDI-DI code

16438153819384

Basic UDI-DI

6438153BU00110B9

Reference / catalog number

981938

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

For in vitro diagnostic use in the quantitative determination of immunoglobulin M (IgM) concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Immunoglobulin M (IgM) test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of primary viral infections and bloodstream infection with parasites including malaria, in patients. Furthermore, the Immunoglobulin tests in general are indicated to be used in conjunction with clinical evaluation for aid to diagnosis of immune deficiencies, autoimmune diseases as well as infections, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102010107IMMUNOGLOBULIN M

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