D2361YH

Dénomination commerciale

non renseigné

06974323012030

B-06974323012030

Numéro de référence/catalogue

D2361YH

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 suitable for the qualitative detection of monkeypox virus nucleic acids extracted from clinical samples such as nasal swabs, oropharyngeal swab, saliva, urine, skin lesion tissue, exudate, and blood, etc. The test results of this kit are for clinical reference only and should not be used as the only standard for clinical diagnosis. Monkeypox virus (MPXV) is a member of the genus Orthopoxvirus and the family Poxviridae. It causes monkeypox, an emerging zoonotic disease recognized as the most important orthopoxvirus infection in humans in the smallpox post-eradication era. The clinical presentation of monkeypox is very similar to the presentation of smallpox, i.e. the febrile prodrome is followed by a skin eruption period. Lymphadenopathy is a typical sign of monkeypox. The case fatality of monkeypox depends on the virus clade, and it falls between 1% and 11%. MPXV can be transmitted both from animal to human (primary transmission) and from human to human (secondary transmission). The virus can enter the body through broken skin (even if not visible), mucous membranes (eyes and mouth), and the respiratory tract.

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.

• W0105040532MONKEYPOX VIRUS / MPOX - NA REAGENT