ONE STEP Barbiturates (BAR) Test

Dénomination commerciale

ONE STEP Barbiturates (BAR) Test

06936155803873

B-06936155803873

Numéro de référence/catalogue

ITP06007-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 Barbiturates (BAR) Test is a rapid, immunochromatographic assay for the detection of barbiturates in human urine. The test is used to screen urine for the presence of barbiturates. 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. Barbiturates are prescription drugs that may be abused and are excreted in urine in unchanged forms, hydroxylated derivatives, carboxylated derivatives and glucuronide conjugates. The test is a qualitative visual screening immunoassay based on a competitive binding principle. Barbiturates in the 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 sufficient sample volume has been added and that the reagents are functioning properly.

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.

• W0102160503BARBITURATES - RT & POC

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

• Avertissement

  For professional in vitro diagnostic use only. This product is designed for detection of barbiturates 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. The test is not suggested for determining the quantitative level of barbiturates in urine and does not indicate the level of intoxication or monitor drug levels. Avoid cross-contamination of urine samples by using a new urine specimen cup for each sample, and do not interpret results after 8 minutes.

• Consulter la notice d’utilisation

  Read and follow the package insert carefully before use.; Do not use past indicated date: Do not use the kit beyond the expiration date printed on the outside of the foil pouch.