MucorGenius® Multiplex real-time PCR kit

Organization name

PathoNostics B.V.

SRN

NL-MF-000002705

Manufacturer status

Active

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• CW010

  Use IFU

Primary placement in Netherlands; available across 1 country total.

Trade name

MucorGenius® Multiplex real-time PCR kit

UDI-DI code

08719326750958

Basic UDI-DI

B-08719326750958

Reference / catalog number

PN-700

Issuing entity

GS1

Risk category

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 MucorGenius® multiplex real-time PCR kit (PN-700) is a real-time PCR kit designed to detect DNA of Mucorales species including Rhizopus spp, Mucor spp, Lichtheimia spp, Cunninghamella spp and Rhizomucor spp. The input sample is total nucleic acid extracted and purified from Bronchoalveolar lavage (BAL), tracheal aspiration, sputum, pleural fluid, paraffin embedded tissue samples (FFPE), biopsy and serum samples. The MucorGenius® real-time PCR kit (PN-700) is validated for use with the NucliSENS® easyMAG® (bioMérieux) and QIAamp® MinElute® Virus Spin kit (Qiagen) for nucleic acid extraction from BAL, tracheal aspiration, sputum, pleural fluid and serum samples. The MucorGenius® real-time PCR assay aids in the diagnosis of mucormycosis in immunocompromised patients when used in combination with other clinical and laboratory findings. Negative results do not necessarily indicate absence of (fungal) infection. Negative results should not be used as the sole basis for diagnosis, therapy, or other treatment decisions. Positive results do not exclude co-infection with other pathogens. The pathogen(s) detected may not be the definite cause of disease. Other laboratory testing and assessment of clinical presentation must be included in the final diagnosis. The product is for use by laboratory professionals only.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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

• W0105060499MYCOLOGY NA REAGENTS - OTHER
• W0105900102REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS