DermaGenius® 2.0 Complete Multiplex real-time PCR kit

Primary DI

08719326750934

Basic UDI-DI Code

87193267509PN-401EQ

Reference

PN-401

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

PathoNostics B.V.

The DermaGenius® 2.0 Complete Multiplex real-time PCR kit is a non-automated, qualitative real-time multiplex PCR test for detection and differentiation of Candida albicans, Trichophyton rubrum/soudanense, Trichophyton interdigitale, Trichophyton tonsurans, Trichophyton mentagrophytes, Trichophyton violaceum, Trichophyton benhamiae, Trichophyton verrucosum, Microsporum canis, Microsporum audouinii and Epidermophyton floccosum DNA which is obtained after nucleic acid extraction with the PathoNostics Extraction kit (PN-502) from nail, hair or skin specimens. The test aids in the diagnosis of onychomycosis and other dermatophytosis disorders, when used in combination with other clinical and laboratory findings. The DermaGenius® 2.0 Complete 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).

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