Develops and manufactures in-vitro diagnostics systems for urine and blood analysis as well as OEM manufacturing for international IVD companies.
Analyticon Biotechnologies GmbH
Lichtenfels-Dalwigksthal (Headquarters, Production) · Lichtenfels-Sachsenberg (Logistics)New on Amplifa
About Analyticon Biotechnologies
Analyticon Biotechnologies GmbH is a German diagnostics company based in Lichtenfels-Dalwigksthal (Waldeck-Frankenberg district) that develops, manufactures and distributes in-vitro diagnostic test systems for urine diagnostics and hematology. The portfolio includes urine test strips (CombiScreen), analyzers such as Urilyzer, Urilyzer Cell and Hemolyzer, reagents, controls and the software UriConnect Pro, with a focus on point-of-care applications in physician practices, hospitals and clinical laboratories. Since 2021, the company has been a subsidiary of the 77 Elektronika Group (Zettwitz family, Budapest); in addition, Analyticon acts as legal manufacturer (OEM) for international IVD companies. All products are developed and manufactured in accordance with DIN EN ISO 13485; supply is provided through a worldwide network of partners and distributors in more than 100 countries. Since 2024, the portfolio has been complemented by test kits for explosive detection as well as service, training and second-level support for business partners.
- Site
- Lichtenfels
- Processes
- Production of in-vitro diagnostic test systems (urine diagnostics and hematology) according to DIN, Production of clinical chemistry reagents (historical, business field discontinued in 2019), Service & Support (second-level support for partners), Training for service technicians and sales staff (training center or on-site), OEM / legal manufacturer production for international IVD companies, Software (UriConnect Pro), Downloads / support portal for business partners
- Materials
- Urine Test Strips, Analyzers and Software
- Certificates
- ISO 13485:2016 (EN ISO 13485:2016/AC:2018, A11:2021), EU Technical Documentation Assessment Certificate (IVDR, EU 2017/746), ISO 13485, IVDR (EU) 2017/746
- Founded
- 1980
- Industries
- In-Vitro Diagnostics (IVD), Urine Diagnostics, Hematology, Point-of-Care, Veterinary Diagnostics, Explosive Detection
- 01
Development
- 02
Production of test strips and reagents
- 03
Assembly and installation of analyzers and software
- 04
Distribution via partners and distributors
- 05
Service and training program
Products and Processes
Urine Test Strips
Own test strip lines (e.g., PLUS with ascorbic acid protection, 12SYS PLUS, mALB/CREA, Auto, VET) for semi-quantitative urine analysis.
Analyzers and Software
Semi- and fully automated reading devices (Urilyzer series), urine sediment analysis (Urilyzer Cell) and hematology analyzers (Hemolyzer 3/5 NG) including the software UriConnect Pro.
Locations
Lichtenfels-Dalwigksthal
DEHeadquarters, production, development and sales of urine diagnostics
- Materials
- Urine test strips, reagents, analyzers
- Urine test strip production facility
- Development
Lichtenfels-Sachsenberg
DELogistics site: storage and shipping of raw materials, semi-finished and finished products as well as analyzers
Products
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Production of in-vitro diagnostic test systems (urine diagnostics and hematology) according to DIN | – | – | – | – | – |
| Production of clinical chemistry reagents (historical, business field discontinued in 2019) | – | – | – | – | – |
12 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Urine test strip analyzer (semi-automatic) | Analyticon Urilyzer 100 Pro | – | – | – | – |
| Urine test strip analyzer (semi-automatic, continuous measurement) | Analyticon Urilyzer 500 Pro | – | – | – | – |
| Urine test strip analyzer (fully automatic) | Analyticon Urilyzer Auto | – | – | – | – |
| Urine sediment analyzer (automatic) | Analyticon Urilyzer Cell | – | – | – | – |
| Workstation for fully automated urine test strip and urine sediment analysis | 77 Elektronika (distributed by Analyticon) LabUMat 2 & UriSed 3 Pro | – | – | – | – |
| Blood count analyzer (3-part/5-part differential blood count) | Analyticon Hemolyzer 3 NG / Hemolyzer 5 NG | – | – | – | – |
| Hematology analyzers | Analyticon Hemolyzer 3 / Hemolyzer 5 | – | – | – | – |
| Urine test strip analyzer | Analyticon CombiScan 500 | – | – | 2003 | – |
| Urine test strip analyzer | Analyticon CombiScan 100 | – | – | 2004 | – |
| Urine test strip analyzer (fully automatic) | Analyticon CombiScan XL | – | – | 2006 | – |
| CombiScreen urine test strip line (e.g., 12SYS PLUS, mALB/CREA, PLUS, Auto, VET) | Analyticon CombiScreen 12SYS Plus 94400/94450 and others | – | – | 2001 | – |
| Explosive detection test kits (distribution, non-IVD) | – | – | – | 2024 | – |
Additional services
Reference customers
Quality
The quality management system complies with EN ISO 13485:2016 (TÜV SÜD, certificate Q5 077568 0010) and the In-Vitro Diagnostic Regulation (EU) 2017/746; Analyticon regularly participates in external interlaboratory trials (among others SKUP, CAP) and ensures continuous quality control across development, production and distribution.
| Evidence | Lichtenfels-Dalwigksthal | Lichtenfels-Sachsenberg |
|---|---|---|
| ISO 13485 | ||
| IVDR (EU) 2017/746 |