ONE STEP Ecstasy (MDMA) Test

Dénomination commerciale

ONE STEP Ecstasy (MDMA) Test

06936155806942

B-06936155806942

Numéro de référence/catalogue

ITP06010-DS50

GS1

IVDD — Général

Législation applicable

IVDD [Directive 98/79/CE relative aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The One Step Ecstasy (MDMA) Test is a rapid, immunochromatographic assay for the detection of MDMA and its metabolites in human urine. The test is used to screen urine for the presence of MDMA and its metabolites. The test is intended for use by healthcare professionals only. This test provides only a preliminary analytical test result. A more specific alternate chemical method must be used in order to obtain a confirmed analytical result. Gas chromatography/mass spectrophotometry (GC/MS) is the preferred confirmatory method. Clinical considerations and professional judgment should be applied to any drug of abuse test result, particularly when preliminary positive results are indicated. MDMA, also known as Ecstasy, is a synthetic drug with stimulant and hallucinogenic properties, and it is metabolized and excreted in urine. The test is a one-step lateral flow chromatographic immunoassay based on a competitive binding principle. MDMA in the urine competes with MDMA-BSA immobilized on the membrane for limited antibody binding sites. A negative specimen produces a visible test line and control line, while a positive specimen produces only the control line. The control line indicates that the test procedure is valid and the reagents are functioning properly.

URL des informations complémentaires

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Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

Nomenclature européenne des dispositifs médicaux — la classification produit UE attribuée à ce dispositif.

• W0102160502AMPHETAMINE/METHAMPHETAMINE SPECIFIC (+ECSTASY) - RT & POC

4 avertissements enregistrés — faire défiler le panneau pour tout voir.

• CW011

  For professional in vitro diagnostic use only. This product is designed for detection of MDMA and its metabolites in human urine only and provides a preliminary qualitative screening result only. Positive results should be confirmed using an alternate method, preferably GC/MS, and clinical considerations and professional judgment should be applied. Avoid contamination during specimen collection, do not mix specimens, and do not interpret results after 8 minutes.
• CW010

  Read and follow the package insert carefully before use.
• CW008

  Dispose of all specimens and used assay materials in a proper biohazard container.
• CW032

  Do not use expired devices.