EDDP

Organization name

Beckman Coulter Ireland Inc.

SRN

IE-MF-000000887

Manufacturer status

Active

Primary placement in Ireland; available across 32 countries total.

Trade name

EDDP

UDI-DI code

15099590030179

Basic UDI-DI

150995902OSR6318N3

Reference / catalog number

OSR6318

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

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• W0102090199DRUGS OF ABUSE - OTHER

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• Expiration date
• Manufacturing date
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