Eu Ivdd
Eu Ivd General
No Longer On The Market
🇫🇮 Finland
Amplidiag Bacterial GE Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
4
Notified Bodies
0
Basic Information
- Primary DI
- 06430041761402
- Basic UDI-DI Code
- B-06430041761402
- Reference
- AD-BGE-100
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- Mobidiag Ltd.
Additional Description
Amplidiag Bacterial GE Kit is a qualitative multiplex nucleic acid-based in vitro diagnostic test intended for diagnosis of community and hospital acquired bacterial infections from stool samples. The assay is based on multiplexed real-time PCR amplification in conjunction with fluorophore-labelled probes. The product consists of test reagent set and software kit configuration containing the analysis parameters.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105070504 | GASTROINTESTINAL INFECTIONS - MULTIPLEX NA REAGENTS |
Available In Countries
🇫🇮 Finland
🇫🇷 France
🇳🇴 Norway
🇸🇪 Sweden
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