Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Helicobacter Pylori and Toxin Nucleic Acid Detection Kit (Fluorescence PCR)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- D-000012807175096R2
- Basic UDI-DI Code
- B-000012807175096R2
- Reference
- HWTS-OT139
- Device Types
- None provided
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Jiangsu Macro & Micro-Test Med-Tech Co., Ltd.
Additional Description
The kit is used for the in vitro qualitative detection of Helicobacter pylori urease A gene and cytotoxin-associated gene A in gastric mucosal biopsy tissue samples and stool samples of patients with suspected Helicobacter pylori infection, and provides aid to the diagnosis of patients with Helicobacter pylori infection.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105010403 | H. PYLORI DETECTION BY NA REAGENTS |
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