Eu Ivdd
Eu Ivd General
On The Market
๐ซ๐ฎ Finland
BIOHIT ๐๐ฆ๐ญ๐ช๐ค๐ฐ๐ฃ๐ข๐ค๐ต๐ฆ๐ณ ๐ฑ๐บ๐ญ๐ฐ๐ณ๐ช UFT300
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06419587020211
- Basic UDI-DI Code
- B-06419587020211
- Reference
- 602021
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Biohit Oyj
Additional Description
BIOHIT Helicobacter pylori UFT300 quick test is a qualitative in vitro test aiding in diagnosis of H. pylori infection from human gastric mucosa by detecting bacterial urease activity in gastric biopsy specimens with biochemical reaction. The test is conducted manually and is intended to be used by healthcare professionals in Near Patient Testing (NPT) settings. Package size: 100 tests per kit.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090102 | H. PYLORI - RT & POC |
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