Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
Rapid H.Pylori Antigen Test Card (3mm)
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06921963711267
- Basic UDI-DI Code
- B-06921963711267
- Reference
- 1O03C42
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Xiamen Boson Biotech Co., Ltd.
Additional Description
Rapid H.Pylori Antigen Test Card is an in vitro qualitative immunochromatographic assay for the rapid detection of Helicobacter pylori antigens in human stool specimen. The test results are intended to aid in the diagnosis of H.Pylori infection, to monitor the effectiveness of therapeutic treatment and to confirm the eradication of H.Pylori in peptic ulcer patients.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0105090102 | H. PYLORI - RT & POC |
Similar Devices
Other on-the-market devices with the same classification (Eu Ivd General) and regulation (EU IVDD).
BluBox
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries
ViroTrack Sero COVID-19 Total Ab
Device
EU IVDD
·
Eu Ivd General
·Blusense Diagnostics ApS·On the market·5 countries
extendSURETM Haemoglobin F and A2 Calibrators
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ Haemoglobin F and A2 Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·8 countries
extendSURE™ HbA1c Liquid Controls
Device
EU IVDD
·
Eu Ivd General
·Canterbury Scientific Limited·On the market·19 countries