DermaGenius® Resistance Multiplex real-time PCR kit

Primary DI

08719327498002

Basic UDI-DI Code

87193274980PN-303FS

Reference

PN-303

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

PathoNostics B.V.

The DermaGenius® Resistance Multiplex real-time PCR kit is a non-automated, qualitative real-time multiplex PCR test for detection and differentiation of T. rubrum/T. soudanense, T. interdigitale/T. mentagrophytes, T. violaceum, T. tonsurans, T. mentagrophytes ITS type IV and T. schoenleinii/T. quinckeanum DNA including identification of the DNA from SQLE wildtype and Leu393 and Phe397 mutated strains which is obtained after nucleic acid extraction with the PathoNostics Extraction kit (PN-502) from nail, hair, skin or culture specimens. The test aids in the diagnosis of onychomycosis and other dermatophytosis disorders which are related to terbinafin resistance, when used in combination with other clinical and laboratory findings. The DermaGenius® Resistance Multiplex real-time PCR kit is for use with LightCycler 480II (Roche), Rotor-Gene-Q (QIAGEN), QuantStudio 5 (Thermo Fisher Scientific), Mic qPCR instrument (BMS) and CFX96 (Biorad). The device is for laboratory-based testing by trained laboratory professionals.

Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).