Monkeypox Virus Nuclear Acid Detection Kit (Real Time PCR)

Primary DI

06974593880124

Basic UDI-DI Code

B-06974593880124

Reference

GZ-MPV100

Device Types

None provided

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

Shanghai GeneoDx Biotech Co., Ltd.

The Monkeypox Virus Nuclear Acid Detection Kit is a real-time fluorescent PCR based assay intended for the qualitative detection of Monkeypox virus (MPV) nucleic acid in serum or lesion exudate samples. Monkeypox virus is a double-stranded DNA, zoonotic virus and a species of the genus Orthopoxvirus in the family Poxviridae. It is one of the human orthopoxviruses that includes variola (VARV), cowpox (CPX), and vaccina (VACV) viruses. Positive results are indicative of the presence of Monkeypox DNA, clinical correlation with patient history and other diagnostic information is necessary to determine patient infection status. The agent detected may not be definite cause of disease. Positive results do not rule out bacterial infection or co-infection with other viruses. Negative results do not preclude Monkeypox 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.

Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).