Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Partners Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

AsperGenius® 2.0 Resistance TR… — IVDD — General IVDD

MD Atlas
PathoNostics B.V.

EUDAMED last updated this device on Jun 15, 2023

AsperGenius® 2.0 Resistance TR Multiplex real-time PCR kit

B-08719326750996

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: PathoNostics B.V.
UDI-DI code: 08719326750996
Reference / catalog number: PN-201

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

View device family (Basic UDI)

Manufacturer information

Organization name: PathoNostics B.V.
SRN: NL-MF-000002705
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
Use IFU

EasyUDICompliance engine

Sponsored

Your devices, UDI-compliant — without drowning in regulation

EUDAMED-ready· UDI-enriched

Basic UDIUDI-DIUDI-PIAttributeDocument

Print-ready label

From your product file — no manual entry

Exclusive to MD Atlas usersClaim my −20% discount

by Made In Tracker

Market distribution

Primary placement in Netherlands; available across 1 country total.

Country	On market since	Until
NetherlandsPrimary placement	May 17, 2022	Still on market

Device identification

Trade name: AsperGenius® 2.0 Resistance TR Multiplex real-time PCR kit
UDI-DI code: 08719326750996
Basic UDI-DI: B-08719326750996
Reference / catalog number: PN-201
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The AsperGenius® 2.0 Resistance TR Multiplex real-time PCR kit (PN-201) is a non-automated, qualitative real-time multiplex PCR test for detection and differentiation of Aspergillus fumigatus cyp51A wildtype, Tandem repeat 34 mutant and Tandem repeat 46 mutant DNA, which is obtained after nucleic acid extraction with a NucliSENS® easyMAG® instrument (BioMérieux) or QIAamp Minelute virus spin kit (QIAGEN) from bronchoalveolar lavage (BAL) samples. The test aids in the diagnosis of pan-azole resistant 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 Resistance TR 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.

UDI-PI traceability

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

UDI-DI DataMatrix

Encoded

(01)08719326750996

Sign in to download the DataMatrix

Create a free account to download the UDI-DI DataMatrix for this device.

Email

Password

No account yet?

EMDN nomenclature code(s)

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

W0105060401ASPERGILLUS - NA REAGENTS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

Become a partner of MD Atlas

Related devices

AsperGenius® 2.0 Species Multiplex real-time PCR kitB-08719326750989On the market DermaGenius® 2.0 Complete Multiplex real-time PCR kit87193267509PN-401EQOn the market MucorGenius® Multiplex real-time PCR kitB-08719326750958On the market PathoNostics Color Calibration kit87193274980PN-507GCOn the market PathoNostics Extraction kit87193267509PN-502EXOn the market

Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.