ONE STEP Tramadol (TRA) Test

Dénomination commerciale

ONE STEP Tramadol (TRA) Test

06936155803613

B-06936155803613

Numéro de référence/catalogue

ITP06014-TC40

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 Tramadol (TRA) Test is a rapid, qualitative assay for determination of tramadol and its metabolites in human urine. The test is used to screen urine for presence of tramadol and its metabolites. The test is for use by healthcare professionals only and provides only a preliminary analytical result; positive results should be confirmed using a more specific method such as GC/MS. Tramadol is a quasi-narcotic analgesic used in the treatment of moderate to severe pain and is extensively metabolized after oral administration. The test is a monoclonal antibody-based competitive immunoassay. Tramadol or its metabolites in urine compete with drug conjugate immobilized on the membrane for limited antibody binding sites. A negative specimen produces two colored bands, while a positive specimen produces only one control band. The control band indicates that the reagents and device are functioning correctly.

URL des informations complémentaires

Aucune URL d'informations complémentaires renseignée par le fabricant.

Dimensions cliniques

Aucune dimension clinique enregistrée pour ce dispositif.

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

• W0102160599DRUGS OF ABUSE/TOXICOLOGY RT & POC - OTHER

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

• CW011

  For professional in vitro diagnostic use only. This product is intended for screening of the specified drug(s) and/or metabolites in human urine only, provides only a preliminary qualitative analytical result, and positive results should be confirmed using a more specific alternate method, preferably GC/MS. Clinical consideration and professional judgment should be applied, particularly when preliminary results are positive. Avoid cross-contamination of urine samples by using a new urine specimen cup for each sample and do not interpret results after 8 minutes
• CW010

  Read and follow the package insert carefully before use
• CW008

  Handle and dispose of residual urine and all used devices in an approved biohazard container
• CW032

  Do not use the kit beyond the expiration date printed on the outside of the foil pouch;