Eu Ivdd Eu Ivd General No Longer On The Market 🇫🇮 Finland

Novodiag Bacterial GE+

Mobidiag Ltd. · 🇫🇮 Finland
Devices (same UDI-DI)
1
Certificates
0
Countries
15
Notified Bodies
0

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Basic Information

Primary DI
06430041761761
Basic UDI-DI Code
B-06430041761761
Reference
NVD-BGE-012
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
No Longer On The Market
Manufacturer
Mobidiag Ltd.

Additional Description

"Novodiag Bacterial GE+ assay is an integrated sample-to-answer cartridge product, composed of sample preparation, DNA amplification, microarray hybridization detection and automated qualitative result interpretation via an assay specific software plug-in. It is designed for diagnosis of community and hospital acquired bacterial infections from stool samples. The product consists of test cartridge and software assay plugin containing the run and analysis parameters."

CND Nomenclature Codes

Code Description
W0105070504 GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS

Available In Countries

🇦🇹 Austria 🇧🇪 Belgium 🇩🇪 Germany 🇩🇰 Denmark 🇪🇸 Spain 🇫🇮 Finland 🇫🇷 France 🇮🇪 Ireland 🇮🇹 Italy 🇱🇺 Luxembourg 🇳🇱 Netherlands 🇳🇴 Norway 🇵🇹 Portugal 🇸🇪 Sweden 🇬🇧 United Kingdom

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