Complement C4

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

Complement C4

UDI-DI code

16438153819322

Basic UDI-DI

6438153BU00179CD

Reference / catalog number

981932

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

NTENDED PURPOSE / INTENDED USE For in vitro diagnostic use in the quantitative determination of Complement C4 concentration in human serum and plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ analyzers. The Complement C4 test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of diseases, which lead to decreased C4 concentration, such as complement deficiency, systemic lupus erythematosus (SLE), sepsis and hereditary and acquired angioedema, in patients. Furthermore, the Complement C4 test is indicated to be used in conjunction with clinical evaluation for aid to assessment of the disease activity in SLE and other autoimmune diseases, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102010205COMPLEMENT COMPONENT C4

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