FANas

Leipzig, Germany

We develop, produce and distribute 13C and H2 breath test devices – Made in Germany in Leipzig. 13/12CO2 breath gas analyzers from Fischer ANalysen Instrumente GmbH are used worldwide for all investigations in the course of which 13C-stable isotope-labeled tracer substances are broken down in the organism and excreted via respiration. The best-known application is the detection of Helicobacter pylori infection with the help of 13C urea kits from different manufacturers (Urea Breath Test). The handy H2 monitor LactoFAN2 shows the hydrogen content in the exhaled air of humans in the ppm range. It is used in the clarification of intolerances of the intestinal tract after ingestion of lactose, fructose, sugar substitutes such as sorbitol or xylitol, but also in the case of incorrect colonization of the small intestine with bacteria (SIBO). Up to 6 patients can be tested at the same time. The breath test data is stored in the device and can be transferred to a PC. All analyzers can be connected to hospital and laboratory information systems via optionally available software. Our company is certified according to Medical Device Directive 93/42/EEC, Annex II, Article 3 and EN ISO 13485:2016. Certification according to the new MDR and IVDR is in progress. Our analyzers are part of the joint FDA approval with our partner Gulf Coast Scientific, Oldsmar, FL for the Helicobacter Test PyloPlus UBT in the US market. We are successfully US FDA inspected. If you have any questions about 13C and H2 breath tests, 13C and H2 breath gas analyzers, breath test kits and substances, we are happy to help.