D2361YH

Trade name

not provided

06974323012030

B-06974323012030

Reference / catalog number

D2361YH

GS1

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105040532MONKEYPOX VIRUS / MPOX - NA REAGENT