Eu Ivdd
Eu Ivd General
No Longer On The Market
🇫🇮 Finland
Amplidiag H. pylori+ClariR Kit
Devices (same UDI-DI)
1
Certificates
0
Countries
4
Notified Bodies
0
Basic Information
- Primary DI
- 06430041761327
- Basic UDI-DI Code
- B-06430041761327
- Reference
- AD-HP-80
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- No Longer On The Market
- Manufacturer
- Mobidiag Ltd.
Additional Description
Amplidiag H. pylori+ClariR Kit is a qualitative multiplexed nucleic acid-based in vitro diagnostic test intended for detecting the presence of nucleic acid markers for the identification Helicobacter pylori and mutations causing clarithromycin resistance. 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 |
|---|---|
| W0105010403 | H. PYLORI DETECTION BY NA REAGENTS |
Available In Countries
🇫🇮 Finland
🇫🇷 France
🇳🇴 Norway
🇸🇪 Sweden
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