Development, production and distribution of 13C and H2 breath test devices for medical diagnostics
Fischer Analysen Instrumente GmbH
Leipzig (Brahestr. 25-27)New on Amplifa
About Fischer Analysen Instrumente
Fischer Analysen Instrumente GmbH (FAN) develops, produces and distributes 13C and H2 breath test devices at its Leipzig site. The 13/12CO2 breath gas analyzers operate on the basis of infrared spectroscopy (NDIRS) and are an alternative to mass spectrometric methods, including for Helicobacter pylori tests, gastric emptying tests and liver function tests. The handheld H2 monitor LactoFAN2 measures hydrogen in the ppm range and allows storage and PC transfer of measurement data. The portfolio also includes software with test protocols, report generation and laboratory information system integration, service for 15N analyzers, as well as accessories and consumables such as autosamplers, breath bags, mouthpieces and test substances. The company is certified to EN ISO 13485 and supplies medical technology, in-vitro diagnostics and gastroenterology as well as international markets. In 2025, FAN was acquired by the SSI Diagnostica Group.
- Site
- Leipzig
- Processes
- Development, production and distribution of 13C and H2 breath test devices (breath gas analysis), 13/12CO2 breath gas analysis based on NDIRS (infrared spectroscopy) as an alternative to, H2 breath gas analysis in the ppm range (LactoFAN2), Manufacture of breath test kits and substances (consumables: bags, mouthpieces,, Development of software for breath tests (test protocols, report generation,, Service for 15N analyzers, Software with test protocols, report generation and laboratory information system integration, Accessories and consumables (autosamplers, breath bags, mouthpieces, test substances)
- Materials
- 13/12CO2 breath gas analysis (infrared spectroscopy), H2 breath gas analysis in the ppm range
- Certificates
- EN ISO 13485:2016
- Founded
- 1991
- Employees
- 11–50
- Industries
- Medical technology, In-vitro diagnostics, Gastroenterology, Medical diagnostics
- 01
Development
- 02
Production
- 03
Software
- 04
Distribution
- 05
Service
- 06
Consumables
Processes and Measurement Technology
13/12CO2 breath gas analysis (infrared spectroscopy)
Alternative to mass spectrometric methods for 13C stable isotope-labeled tracer substances.
H2 breath gas analysis in the ppm range
Handheld monitor LactoFAN2 with data storage and PC transfer.
Locations
Leipzig
DEDevelopment, production and distribution (headquarters)
- FANci2-db16 (dual-beam infrared spectrometer)
- FANci2-sb16 (single-beam infrared spectrometer)
- HeliFANplus
- LactoFAN2
- Autosampler
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Development, production and distribution of 13C and H2 breath test devices (breath gas analysis)Engineering | – | – | – | – | – |
| 13/12CO2 breath gas analysis based on NDIRS (infrared spectroscopy) as an alternative toTesting | – | – | – | – | – |
| H2 breath gas analysis in the ppm range (LactoFAN2)Testing | – | – | – | – | – |
| Manufacture of breath test kits and substances (consumables: bags, mouthpieces,Assembly | – | – | – | – | – |
| Development of software for breath tests (test protocols, report generation,Engineering | – | – | – | – | – |
| Service for 15N analyzersTesting | – | – | – | – | – |
5 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| 13C breath gas analyzer (dual-beam infrared spectrometer) | Fischer Analysen Instrumente GmbH FANci2-db16 | – | 16 sample ports, USB interface, PC/notebook from Windows 7 | – | Leipzig |
| 13C breath gas analyzer (single-beam infrared spectrometer) | Fischer Analysen Instrumente GmbH FANci2-sb16 | – | 16 sample ports, USB interface, PC/notebook from Windows 7 | – | Leipzig |
| 13C breath test device (compact single-beam infrared analyzer, H. pylori test) | Fischer Analysen Instrumente GmbH HeliFANplus | – | Interfaces: USB, serial, printer connection, CAN bus | – | Leipzig |
| H2 breath test device / handheld monitor (ppm range) | Fischer Analysen Instrumente GmbH LactoFAN2 | – | – | – | Leipzig |
| Autosampler (accessory for gas analyzers) | Fischer Analysen Instrumente GmbH | – | – | – | Leipzig |
Additional services
Reference customers
Quality
The quality management system is certified to EN ISO 13485:2016 by TÜV Rheinland LGA Products GmbH (certificate SX 1566681-1, valid until 2028-04-08). Scope: development, production, distribution, installation and service of in-vitro diagnostics for breath gas analysis devices as well as distribution of consumables.
| Evidence | Leipzig |
|---|---|
| EN ISO 13485:2016 |
History
- 1991
Foundation of Fischer Analysen Instrumente GmbH
- 2012
Martin Schaich becomes CEO and owner
- 2025
Acquisition of FAN GmbH by SSI Diagnostica Group (May, following the acquisition of Gulf Coast Scientific in 2025)