B05201T2048

Dénomination commerciale

non renseigné

06970895475839

B-06970895475839

Numéro de référence/catalogue

B05201T2048

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 Clarithromycin, Quinolone-Resistant and Non-Resistant Helicobacter Pylori Nucleic Acid Amplification Test Kit is a non-automated in vitro diagnostic test, based on multiplex real-time PCR, for the qualitative detection of Helicobacter pylori (H.pylori) nucleic acid DNA and mutation sites related to Clarithromycin and Quinolones resistance from human feces specimens. The kit is suitable for patients with H. pylori infection or suspected infection. The kit is intended as an aid in the diagnosis of infection with H.pylori as well as resistance to Clarithromycin and Quinolones, if present, in combination with patient history and additional clinical information. The kit is for professional use only and its use is limited to qualified personnel instructed in real-time PCR and in vitro diagnostic procedures.

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.

• W0105010403H. PYLORI DETECTION BY NA REAGENTS