Eu Ivdd
Eu Ivd Self Testing
On The Market
🇨🇳 China
H.pylori Antigen Rapid Test Cassette
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 06936983152662
- Basic UDI-DI Code
- B-06936983152662
- Reference
- IHP-602H
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd Self Testing
- Status
- On The Market
- Manufacturer
- Hangzhou Alltest Biotech.Co.,Ltd.
Additional Description
The Helicobacter Pylori Self-test (Feces) is a rapid chromatographic immunoassay for the qualitative detection of H. pylori antigens in human feces specimens, providing results in 10 minutes. The test utilizes antibodies specific for H. pylori antigens to selectively detect H. pylori antigens in human feces specimens.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090102 | H. PYLORI - RT & POC |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | No.V10951230008 | TÜV SÜD Product Service GmbH | Expired |
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