HELICOBACTER PYLORI Ag VIRCLIA® MONOTEST
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Basic Information
- Primary DI
- 08436610290104
- Basic UDI-DI Code
- 843661029VCM10301LA
- Reference
- VCM103
- Device Types
- None provided
- Regulation
- Eu Ivdr
- Classification
- Eu Ivd Class B
- Status
- On The Market
- Manufacturer
- Vircell, S.L
Additional Description
Sandwich chemiluminescent immunoassay (CLIA) for the detection of Helicobacter pylori antigen in human stool samples. The device is intended to be used with general population with suspected infection by the microorganism. The test is a qualitative and automated assay, intended to be used as an aid to diagnosis.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010401 | H. PYLORI ANTIGEN DETECTION |
Available In Countries
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Similar Devices
Other on-the-market devices with the same classification (Eu Ivd Class B) and regulation (EU IVDR).