Eu Ivdd
Eu Ivd General
On The Market
🇨🇳 China
RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER
Devices (same UDI-DI)
1
Certificates
0
Countries
0
Notified Bodies
0
Basic Information
- Primary DI
- 06977412420792
- Basic UDI-DI Code
- B-06977412420792
- Reference
- 50 test
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- Shanghai Zymetas Medtech Co., Ltd
Additional Description
H. pylori Antigen Rapid Test is a single use immunochromatographic assay for the qualitative detection of H. pylori antigen in human stool specimens. Test results are intended to aid in the initial diagnosis and treatment of H. pylori infection. Test results should be taken into consideration by the physician in conjunction with the patient history and symptoms.
CND Nomenclature Codes
| Code | Description |
|---|---|
| W01021699 | RAPID TESTS & POINT OF CARE - IMMUNOCHEMISTRY - OTHER |
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