Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
H. PYLORI - RT & POC
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- D-CNM0000180728022NN
- Basic UDI-DI Code
- B-CNM0000180728022NN
- Reference
- 8022C
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Shanghai Chemtron Biotech Co., Ltd.
Additional Description
H.pylori Antigen Rapid Test is a rapid, visual immunochromatographic test for the qualitative detection of Helicobacter Pylori antigen in fecal samples. This test is intended as an aid in the diagnosis of Helicobacter Pylori infection. It is intended for self-testing.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090102 | H. PYLORI - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | V1 076482 0004 | TÜV SÜD Product Service GmbH | Expired |
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