Monkeypox Virus Real-time PCR Kit

Dénomination commerciale

Monkeypox Virus Real-time PCR Kit

06971225937331

B-06971225937331

Numéro de référence/catalogue

GPCR130024

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 product is a real-time polymerase chain reaction (PCR) test intended for qualitative detection of the nucleic acid of the monkeypox virus (MPXV) in skin lesion material (including swabs of lesion exudate, lesion roofs, lesion crusts), oropharyngeal swabs, serum samples. Results are for the identification of MPXV nucliec acids that is generally detectable in the samples mentioned above. Positive results are indicative of the presence of MPXV nucleic acid; clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude MPXV infection and should not be used as the sole basis for patient management decisions. Negative results must be combined with clinical observations, patient history, and epidemiological information. This kit is intended for use by trained clinical laboratory personnel specifically instructed and trained in the techniques of real-time PCR and in vitro diagnostic procedures. For in vitro diagnostic use. For professional use.

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.

• W0105099008MONKEYPOX VIRUS / MPOX RT & POC