PneumoGenius® Multiplex real-time PCR kit

Primary DI

08719326750941

Basic UDI-DI Code

B-08719326750941

Reference

PN-600

Device Types

Single use

Regulation

Eu Ivdd

Classification

Eu Ivd General

Status

On The Market

Manufacturer

PathoNostics B.V.

The PneumoGenius® is a real-time PCR assay which detects P. jirovecii, and simultaneous identifies two point mutations in the DHPS fas gene. The PneumoGenius® real-time PCR assay aids in the diagnosis of Pneumocystis pneumonia 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).