DermaGenius® 3.0 Complete Multiplex real-time PCR kit

Primary DI

08719327498019

Basic UDI-DI Code

87193274980PN-402FV

Reference

PN-402

Device Types

Single use

Regulation

Eu Ivdr

Classification

Eu Ivd Class B

Status

On The Market

Manufacturer

PathoNostics B.V.

The DermaGenius® 3.0 Complete Multiplex real-time PCR kit is a non-automated, qualitative real-time multiplex PCR test for detection and differentiation of C. albicans, C. parapsilosis, S. brevicaulis, T. rubrum/T. soudanense, T. interdigitale/T. mentagrophytes, T. violaceum, T. tonsurans, T. mentagrophytes ITS type IV, T. schoenleinii/T. quinckeanum, T. benhamiae, T. verrucosum, M. canis, M. audouinii, E. floccosum, N. gypsea and generic dermatophyte 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® 3.0 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).