DermaGenius® 2.0 Complete Multiplex real-time PCR kit

Organization name

PathoNostics B.V.

SRN

NL-MF-000002705

Manufacturer status

Active

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• CW010

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Primary placement in Netherlands; available across 1 country total.

Trade name

DermaGenius® 2.0 Complete Multiplex real-time PCR kit

UDI-DI code

08719326750934

Basic UDI-DI

87193267509PN-401EQ

Reference / catalog number

PN-401

Issuing entity

GS1

Risk category

IVDR Class B

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

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).

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

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European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105060402CANDIDA ALBICANS - NA REAGENTS