Development and marketing of reagents, analyzers and software for transfusion and transplantation diagnostics
Immucor Medizinische Diagnostik GmbH
Dreieich (Headquarters)New on Amplifa
About Immucor Medizinische Diagnostik GmbH
Immucor Medizinische Diagnostik GmbH, headquartered in Dreieich (Hesse), has been active in the field of transfusion and transplantation diagnostics for more than 30 years; according to the company, its innovation tradition dates back to 1982. The company develops and markets diagnostic laboratory tests as well as blood bank analyzers and software solutions. The portfolio includes traditional reagents, analyzers such as NEO® and NEO Iris®, the Echo Lumena® analysis instrument for antibody identification, and molecular and NGS-based products for HLA typing. Further product lines relate to coagulation diagnostics and antibody detection. The company belongs to the Werfen group (Specialized Diagnostics) and is a partner to hospitals, reference laboratories and donor centers worldwide, including, according to its website, the Hospital of the University of Pennsylvania and University Hospital Southampton. With branches and distribution partners in Europe, North and South America, Asia, the Middle East, Africa and Australia, customers are served globally.
- Site
- Dreieich
- Processes
- Manufacture/marketing of diagnostic laboratory tests (reagents), Development and marketing of laboratory analyzers (Blood Bank Automation), Transfusion Diagnostics, Transplantation Diagnostics (HLA Typing), Coagulation Diagnostics, Molecular/NGS, Automation, Software Solutions
- Materials
- Capture® Solid-Phase Technology, Molecular Diagnostics / Next Generation Sequencing
- Certificates
- EN ISO 13485:2016, EC Certificate Full QA System, EU Certificate 2017/746 Annex IX (Class C and D)
- Industries
- Medical Technology, In Vitro Diagnostics, Blood Banks, Transplantation Laboratories, Hospitals, Reference Laboratories
- 01
Research and Development
- 02
Reagent Manufacturing
- 03
Development of Laboratory Analyzers and Software
- 04
Regulatory Certification (IVDR)
- 05
Sales and Customer Service
- 06
Training (Werfen Academy)
Product Lines and Technologies
Capture® Solid-Phase Technology
Patented solid-phase technology for a broad test menu in blood bank diagnostics.
Molecular Diagnostics / Next Generation Sequencing
NGS-based HLA typing, including NanoTYPE™ HLA-11 Plus for all 11 classical HLA genes.
Locations
Dreieich
DEHeadquarters and German branch
- Materials
- Transfusion, Transplantation, Coagulation, Molecular/NGS
- NEO® (Blood Bank Analyzer)
- NEO Iris® (Blood Bank Analyzer)
- Echo Lumena® (Analysis Instrument)
Products and Systems
Inside the production
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacture/marketing of diagnostic laboratory tests (reagents)Testing | – | – | – | – | – |
| Development and marketing of laboratory analyzers (Blood Bank Automation)Assembly | – | – | – | – | – |
3 Anlagen & Maschinen
| Machine | Manufacturer / model | Quantity | Working area | Year built | Site |
|---|---|---|---|---|---|
| Blood Bank Analyzer (Blood Bank Automation) | Immucor NEO® | – | – | – | – |
| Blood Bank Analyzer | Immucor NEO Iris® | – | – | – | – |
| Analysis Instrument (Antibody Identification) | Immucor Echo Lumena® | – | – | – | – |
Additional services
Reference customers
Quality and Certification
The quality system at the Dreieich site is certified to EN ISO 13485:2016; in addition, an EC certificate for a full QA system and an EU certificate under Regulation (EU) 2017/746 Annex IX (Class C and D) are held.
| Evidence | Dreieich |
|---|---|
| EN ISO 13485:2016 | |
| EC Certificate Full QA System | |
| EU Certificate 2017/746 Annex IX (Class C and D) |
History
- 1982
Start of innovation activity in transfusion and transplantation diagnostics (according to website: "Since 1982")
Acquisition of Omixon by Werfen (year not specified)