Singclean®

Dénomination commerciale

Singclean®

06936020140416

69360201528X

Numéro de référence/catalogue

M90-05-25t

GS1

IVDR Classe B

Législation applicable

IVDR [Règlement (UE) 2017/746 relatif aux dispositifs médicaux de diagnostic in vitro]

Statut

Sur le marché

Quantité

1

Description complémentaire du produit

The Multi-Drug One Step Test Kit (Colloidal Gold Method) (BZO/BAR/MDMA/MTD/OXY)is a rapid chromatographic immunoassay for the qualitative detection for the drugs and drug metabolites in human urine. It is mainly used for aiding to diagnosis the drug dependence and drug withdrawal, and it's not for monitoring purpose.

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.

• W0102090199DRUGS OF ABUSE - OTHER

1 avertissement enregistré — faire défiler le panneau pour tout voir.

• CW010

   For in vitro diagnostic use only.  For professional laboratory use, and the users should have relevant qualifications.  Do not use after the expiration date indicated on the package. Do not use the test if its foil pouch is damaged. Do not reuse tests.  After use, put all components back into their original aluminum foil bags or packaging bags, and dispose of the discarded packaging according to local regulations  All specimens should be considered potentially hazardous and handle in the same way as an infectious material.  Avoid cross-contamination of specimens by using a new specimen collection container and specimen pipette for each specimen obtained.  Read the entire procedure carefully prior to performing any tests.  The used testing materials should be discarded in accordance with local, state and/or federal regulations.  Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State.