Eu Ivdd
Eu Ivd General
No Longer On The Market
🇫🇮 Finland
Amplidiag CarbaR+ MCR Kit
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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