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🇪🇺EU · EMAAuthorisedATC: V04CX

Helicobacter Test INFAI(urea (13C))

Breath Tests;Helicobacter Infections

Marketing Authorisation Holder: INFAI, Institut für biomedizinische Analytik NMR-Imaging GmbH

EMA Authorisation: 14/08/1997

INN: 13C-urea

Indication

Helicobacter Test INFAI may be used for in vivo diagnosis of gastroduodenal Helicobacter pylori infection in: adults; adolescents, who are likely to have peptic ulcer disease. Helicobacter Test INFAI for children aged three to 11 years may be used for in vivo diagnosis of gastrduodenal Helicobacter pylori infection: for the evaluation of the success of eradication treatment, or; when invasive tests cannot be performed, or; when there are discordant results arising from invasive tests. This medicinal product is for diagnostic use only.

Official EMA Resources

View on EMA (ema.europa.eu)

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Medical disclaimer: This information is intended for qualified healthcare professionals. Always verify with the official EMA Summary of Product Characteristics (SmPC) before clinical use.