H.Pylori Antigen Test Kit

Trade name

H.Pylori Antigen Test Kit

UDI-DI code

06952062711704

Basic UDI-DI

69520627J016LB

Reference / catalog number

HPAg4FEST-2

Issuing entity

GS1

Risk category

IVDR Class C

Applicable legislation

IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]

Status

On the market

Quantity

2

Additional product description

This product is used for the qualitative detection of Helicobacter pylori antigen in human fecal specimens. It is a non-automated rapid test designed for infection diagnosis, specifically to aid in diagnosing Helicobacter pylori infection in individuals. The test is authorized for non-prescription home use with self-collected fecal specimens.

Additional information URL

No additional information URL provided by the manufacturer.

Clinical sizes

No clinical sizes registered for this device.

European Medical Device Nomenclature — the EU product classification assigned to this device.

• W0105090102H. PYLORI - RT & POC

3 warnings recorded — scroll inside the panel to see all entries.

• CW010

  EUDAMED did not publish a description for this code.
• CW009

  EUDAMED did not publish a description for this code.
• CW007

  EUDAMED did not publish a description for this code.