D-Dimer

Organization name

Thermo Fisher Scientific Oy

SRN

FI-MF-000001479

Manufacturer status

Active

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• CW129

  Contains 2-chloracetamid

Primary placement in Finland; available across 28 countries total.

Trade name

D-Dimer

UDI-DI code

16438153000744

Basic UDI-DI

6438153BU00062BP

Reference / catalog number

981946

Issuing entity

GS1

Risk category

IVDR Class C

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 D-dimer concentration in human plasma with the automated procedures of Thermo Scientific™ Indiko™ and Konelab™ (60, 30, 20XT) analyzers. The D-Dimer test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis and monitoring of venous thromboembolism (VTE), disseminated intravascular coagulation (DIC) and fibrinolytic states, in patients. In particular, the D-Dimer test is indicated to be used in conjunction with clinical evaluation as aid for excluding VTE in patients, specifically deep vein thrombosis (DVT) and pulmonary embolism (PE). Furthermore, the D-Dimer test is indicated to be used in conjunction with clinical evaluation for aid to diagnosis of a recurrent thrombotic risk following anticoagulation, post-surgical state, significant liver disease, malignancy and normal pregnancy, in patients.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0103020503D-DIMER

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