AsperGenius® 2.0 Species Multiplex real-time PCR 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

AsperGenius® 2.0 Species Multiplex real-time PCR kit

UDI-DI code

08719326750989

Basic UDI-DI

B-08719326750989

Reference / catalog number

PN-101

Issuing entity

GS1

Risk category

IVDD — General

Applicable legislation

IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]

Status

On the market

Quantity

1

Additional product description

The AsperGenius® 2.0 Species Multiplex real-time PCR kit (PN-101) is a non-automated, qualitative real-time multiplex PCR test for detection and differentiation of Aspergillus fumigatus, Aspergillus terreus, Aspergillus flavus and DNA of other Aspergillus species which is obtained after nucleic acid extraction with a NucliSENS® easyMAG® instrument (BioMérieux) or QIAamp Minelute virus spin kit (QIAGEN) from bronchoalveolar lavage (BAL). The test aids in the diagnosis of invasive pulmonary aspergillosis (IPA) in ‘at risk’ patients (humans), such as patients with hematological malignancies , solid organ transplant (SOT) and allogeneic transplant recipients, patients with chronical lung diseases (eg. CF, COPD) and as a co-infection with other infections, when used in combination with other clinical and laboratory findings. The AsperGenius® 2.0 Species Multiplex real-time PCR kit is for use with LightCycler® 480 II (Roche), Rotor-Gene® Q (QIAGEN), QuantStudio™ 5 (Thermo Fisher Scientific), Mic qPCR instrument (BMS) and CFX96™ (Bio-Rad).

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.

• W0105060401ASPERGILLUS - NA REAGENTS