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

Amplidiag CarbaR+ MCR Kit

Mobidiag Ltd. · 🇫🇮 Finland
Devices (same UDI-DI)
1
Certificates
0
Countries
4
Notified Bodies
0

Basic Information

Primary DI
06430041761464
Basic UDI-DI Code
B-06430041761464
Reference
AD-CPM-100
Device Types
Single use
Regulation
Eu Ivdd
Classification
Eu Ivd General
Status
No Longer On The Market
Manufacturer
Mobidiag Ltd.

Additional Description

Amplidiag CarbaR+MCR identifies clinically most relevant carbapenemase groups as well as colistin resistance markers in one single test. This molecular diagnostic test has been designed to be a cost-effective solution for high-volume screening directly from stool, rectal swabs and pure culture samples for the diagnosis of carbapenemase-producing organisms (CPO) and colistin-resistant Enterococci (CRE). This qualitative multiplex real-time PCR test gives results within a few hours. The product consists of test reagent set and software kit configuration containing the analysis parameters.

CND Nomenclature Codes

Code Description
W0104080607 NUCLEIC ACID IDENTIFICATION - MANUAL / AUTOMATED OTHER RESISTANCE MARKERS

Available In Countries

🇫🇮 Finland 🇫🇷 France 🇳🇴 Norway 🇸🇪 Sweden

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