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

Novodiag RESP-4

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

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Basic Information

Primary DI
06430041761525
Basic UDI-DI Code
B-06430041761525
Reference
Novodiag RESP-4
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
No Longer On The Market
Manufacturer
Mobidiag Ltd.

Additional Description

The Novodiag® RESP-4 test is a molecular random-access test, easy to use that aids in the detection and differentiation of RNA from SARS-CoV-2, influenza A and B and RSV A/B viruses. The test includes two SARS-CoV-2 specific gene targets and reports them separately to eliminate false negative results due to potential target mutations. The test detects also clinically associated influenza A subtypes and clades of A(H1N1), A(H3N2), and A(H5N1), and their variants as well as two influenza B lineages: B/Yamagata and B/Victoria and RSVA and B.

CND Nomenclature Codes

Code Description
W0105070503 RESPIRATORY TRACT 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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