D-DIMER
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Basic Information
- Primary DI
- 15099590000332
- Basic UDI-DI Code
- 150995901OSR60135SL
- Reference
- OSR60135
- Device Types
-
Single use
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class C
- Status
- On The Market
- Manufacturer
- Beckman Coulter Inc.
Additional Description
D-Dimer reagent is an in vitro diagnostic medical device intended to be used by healthcare professionals for the quantitative immunoturbidimetric measurement of D-Dimer in human plasma using the automated Beckman Coulter AU/DxC AU analyzers. Measurement of D-Dimer is intended to be used as an aid to the diagnosis of Intravascular coagulation disorders including Deep Vein Thrombosis (DVT), Pulmonary Embolism (PE) and Disseminated Intravascular Coagulation (DIC). D-Dimer is generally used for its negative predictive value.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0102019099 | SPECIFIC PROTEINS - OTHER |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class C) and regulation (EU IVDR).