Monkeypox Virus Real-time PCR Kit

Trade name

Monkeypox Virus Real-time PCR Kit

06971225937225

B-06971225937225

Reference / catalog number

GPCR130048

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

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.

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.

• W0105099008MONKEYPOX VIRUS / MPOX RT & POC