6-Monoacetylmorphine(6-MAM) Rapid Test(Saliva)

Dénomination commerciale

6-Monoacetylmorphine(6-MAM) Rapid Test(Saliva)

Code d'IUD-ID

D-6974246466-MAM002D7XQ

IUD-ID de base

B-6974246466-MAM002D7XQ

Numéro de référence/catalogue

6-MAM-7011/6-MAM-7012/6-MAM-7014/6-MAM-7015

Entité d'attribution

EUDAMED

Catégorie de risque

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 6-Monoacetylmorphine(6-MAM) Rapid Test(Saliva) is an immunoassay based on the principle of competitive binding. Drugs that may be present in the oral fluid specimen compete against their respective drug conjugate for binding sites on their specific antibody. During testing, a portion of the oral fluid specimen migrates upward by capillary action. A drug, if present in the oral fluid specimen below its cut-off concentration, will not saturate the binding sites of its specific antibody. The antibody will then react with the drug-protein conjugate and a visible colored line will show up in the test line region of the specific drug strip. The presence of drug above the cut-off concentration in the oral fluid specimen will saturate all the binding sites of the antibody. Therefore, the colored line will not form in the test line region. A drug-positive oral fluid specimen will not generate a colored line in the specific test line region of the strip because of drug competition, while a drug-negative oral fluid specimen will generate a line in the test line region because of the absence of drug competition. To serve as a procedural control, a colored line will always appear at the control line region, indicating that proper volume of specimen has been added and membrane wicking has occurred."

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

Aucun certificat ne référence l'IUD-ID de base de ce dispositif.