EDDP

Primary DI

15099590030179

Basic UDI-DI Code

150995902OSR6318N3

Reference

OSR6318

Device Types

None provided

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

Beckman Coulter Ireland Inc.

EDDP reagent is an in vitro diagnostic medical device intended to be used by healthcare professionals for the qualitative and semi-quantitative homogeneous enzyme immunoassay measurement of EDDP in human urine using the automated Beckman Coulter AU/DxC AU analyzers. Measurement of EDDP is intended to be used as an aid to the management of patients on methadone treatment. The assay provides only a preliminary analytical test result. A more specific alternative chemical method must be used to obtain a confirmed analytical result. Gas chromatography/mass spectrometry (GC/MS) is the preferred confirmatory method.1 Clinical consideration and professional judgement should be applied to any drug of abuse test result particularly when using a preliminary positive result.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).