MucorGenius® Multiplex real-time PCR kit

Primary DI

08719326750958

Basic UDI-DI Code

B-08719326750958

Reference

PN-700

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PathoNostics B.V.

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.

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