PathoNostics Extraction kit

Organization name

PathoNostics B.V.

SRN

NL-MF-000002705

Manufacturer status

Active

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• CW010

  Use IFU

Primary placement in Netherlands; available across 1 country total.

Trade name

PathoNostics Extraction kit

UDI-DI code

08719326750965

Basic UDI-DI

87193267509PN-502EX

Reference / catalog number

PN-502

Issuing entity

GS1

Risk category

IVDR Class A

Applicable legislation

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

Status

On the market

Quantity

1

Additional product description

The PathoNostics® Extraction kit is a non-automated in vitro medical device accessory which possesses no critical characteristics. It is intended for isolation of nucleic acids from fungal pathogens, present on human nail, hair and skin samples or fungal cultures derived from these specimens, to be used as template material with the DermaGenius® product line: (PN-301) DermaGenius® 2.0 Nail Multiplex real-time PCR kit (PN-401) DermaGenius® 2.0 Complete Multiplex real-time PCR kit (PN-402) DermaGenius® 3.0 Complete Multiplex real-time PCR kit (PN-303) DermaGenius® Resistance Multiplex real-time PCR kit

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

• Batch number
• Expiration date
• Manufacturing date
• Serial number
• Software identification

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

• W0105900101REAGENTS FOR DNA AND/OR RNA EXTRACTION AND PREPARATION: BACTERIA AND/OR VIRUS