R23203T2012

Dénomination commerciale

non renseigné

06970895476041

B-06970895476041

Numéro de référence/catalogue

R23203T2012

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

This kit is a non-automated in vitro diagnostic test, based on multiplex real-time PCR, for the qualitative detection and differentiation of nucleic acids from 40 microbes and 4 mutation sites of Mycoplasma pneumoniae that are resistant to macrolide antibiotics, in the oropharyngeal swab, nasopharyngeal swab, sputum and alveolar lavage fluid specimens collected from patients or suspected patients with respiratory tract disease. The kit is intended for use as an aid in the detection and differential diagnosis of the above 40 microbes and 4 mutation sites of Mycoplasma pneumoniae that are resistant to macrolide antibiotics in humans in conjunction with clinical and epidemiological risk factors. For laboratory professional use only.The detection of Chlamydia and Rubella virus are for research use only.

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.

• W0105070503RESPIRATORY TRACT INFECTIONS - MULTIPLEX NA REAGENTS