Development, production and distribution of in-vitro diagnostics systems for urine diagnostics and hematology
Analyticon Biotechnologies GmbH
Lichtenfels (headquarters) · Lichtenfels (Sachsenberg logistics site)New on Amplifa
About Analyticon Biotechnologies
Analyticon Biotechnologies GmbH is a diagnostics company specializing in test systems for urine diagnostics and hematology. The portfolio comprises urine test strips (CombiScreen®), evaluation and analysis devices (CombiScan®, Urilyzer®, LabUmat workstations) as well as analyzers and reagents for hematology (Hemolyzer® line). The products are used for diagnostics in medical practices, hospitals and clinical laboratories and support precise and cost-effective on-site diagnosis. In addition to distribution in more than 100 countries via a worldwide partner network, Analyticon acts as a physical manufacturer (PM/OEM) for international IVD companies. Since 2024, the portfolio has also included test kits for explosive detection. Production, development and distribution take place at the headquarters in Lichtenfels-Dalwigksthal (Hesse); a separate logistics site in Lichtenfels-Sachsenberg handles goods receipt, shipping and storage.
- Site
- Lichtenfels
- Processes
- Development, production and distribution of in-vitro diagnostics reagents (urine diagnostics), Development, production, distribution, service and installation of in-vitro diagnostics analysis, Production of urine test strips (CombiScreen®), Physical manufacturer (PM) for international IVD companies (OEM manufacturing), Service & Support (second-level support for partners worldwide), Training for service technicians and application specialists, Maintenance and commissioning of analysis devices, OEM/private-label manufacturing (physical manufacturer) for international IVD companies
- Certificates
- EN ISO 13485:2016 (AC:2018, A11:2021), IVDR EU Technical Documentation Assessment Certificate (EU) 2017/746, ISO 13485, IVDR (EU) 2017/746
- Founded
- 1980
- Industries
- In-vitro diagnostics, Medical technology, Laboratory and practice supplies, Explosive detection, Laboratory/practice supplies
- 01
Development
- 02
Production of reagents and urine test strips
- 03
Manufacturing, installation and service of analysis devices
- 04
Quality control in accordance with ISO 13485 and IVDR
- 05
Logistics (goods receipt, storage, shipping)
- 06
Distribution via worldwide partner network
- 07
Second-level support and training
Sites
Lichtenfels-Dalwigksthal
DEHeadquarters; development, production and distribution of urine diagnostics; distribution and service for hematology
- Materials
- Reagents, urine test strips, analysis devices
Lichtenfels-Sachsenberg
DELogistics site: goods receipt, shipping, storage of raw materials, semi-finished and finished products and analysis
Vöhl-Marienhagen
DEFormer production site for clinical chemistry (BIOCON, 2011–2019)
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Development, production and distribution of in-vitro diagnostics reagents (urine diagnostics)Testing | – | – | – | – | – |
| Development, production, distribution, service and installation of in-vitro diagnostics analysisAssembly | – | – | – | – | – |
| Production of urine test strips (CombiScreen®)Testing | – | – | – | – | – |
| Physical manufacturer (PM) for international IVD companies (OEM manufacturing)Assembly | – | – | – | – | – |
Additional services
Reference customers
Quality and Certification
The seamless quality control of development, production and distribution is ensured by a quality management system certified in accordance with EN ISO 13485:2016 + AC:2018 + A11:2021 by TÜV SÜD; the products fulfill the requirements of the IVD Regulation (EU) 2017/746. Analyticon regularly participates in external interlaboratory comparisons.
| Evidence | Lichtenfels-Dalwigksthal | Lichtenfels-Sachsenberg |
|---|---|---|
| ISO 13485 | ||
| IVDR (EU) 2017/746 |
Company History
- 1980
Foundation of ANALYTICON Gesellschaft für Analytik, Diagnostik und Controls mbH as a distribution company in Niedernhausen-Engenhan
- 1988
Foundation of BIOCON Diagnosemittel GmbH in Burbach (Siegen); production of clinical chemistry reagents and distribution by Analyticon
- 1997
Relocation to the Waldeck-Frankenberg district: site relocation to Lichtenfels-Dalwigksthal (Analyticon) and Vöhl-Marienhagen (Biocon)
- 1998/1999
Construction of the production facility and development of urine test strips in Dalwigksthal
- 2001
Change of legal form to Analyticon Biotechnologies AG; series production of the CombiScreen® urine test strip line; start of cooperation with 77 Elektronika Kft. (Budapest)
- 2002
Certification in accordance with DIN EN ISO 13485
- 2003
Market launch of the CombiScan® line with the evaluation device CombiScan® 500
- 2010
Establishment of hematology as the second business field with the Hemolyzer® line
- 2011
Merger of BIOCON Diagnosemittel GmbH with Analyticon Biotechnologies AG; Vöhl-Marienhagen becomes the company's second site
- 2012
Market launch of Urilyzer® 100 and Urilyzer® 100 Pro
- 2014
Market launch of the fully automatic Urilyzer® Auto
- 2017
Market launch of Urilyzer® 500 Pro
- 2018
Market launch of Hemolyzer® 3 / 5 NG
- 2019
Focus on urine diagnostics and hematology; discontinuation of the clinical chemistry and coagulation business fields
- 2021
Acquisition by the Zettwitz owner family of the 77 Elektronika Group; change of legal form to Analyticon Biotechnologies GmbH
- 2022
Market launch of Urilyzer® Cell; expansion of the Lichtenfels-Sachsenberg logistics site
- 2023
CombiScreen® Auto ACR; marketing of the LabUmat 2 / UriSed 3 Pro workstation
- 2024
Portfolio expanded to include test kits for explosive detection; certification in accordance with IVDR (EU) 2017/746
- 2025
Market launch of CombiScreen® 12SYS PLUS