HUMAN Gesellschaft für Biochemica und Diagnostica mbH

About HUMAN Diagnostics

HUMAN Gesellschaft für Biochemica und Diagnostica mbH develops and manufactures in-vitro diagnostics (IVD) for clinical laboratories, medical facilities and global health. The portfolio comprises around 400 products from twelve IVD disciplines: clinical chemistry, haematology, haemostasis, ELISA, fluorescence immunoassays (FIA), rapid tests, urinalysis, microscopes, laboratory equipment, diabetes, point-of-care, molecular and autoimmune diagnostics. Production takes place in Germany at the Magdeburg site (reagents) and Ahrensburg site (LABiTec, device manufacturing); manufacturing is ISO certified. Founded in 1972 in Taunusstein and headquartered in Wiesbaden, the company employs around 300 people and supplies more than 160 countries through a worldwide distribution network. In addition to its own products, HUMAN provides OEM manufacturing as well as global supply and regulatory services including registration support. A training centre in Nairobi plus regional offices in Asia, the Middle East and Latin America complete the worldwide service.

Site

Wiesbaden

Processes

Global Support Services (technical support via local partners up to the Wiesbaden competence centre), Global supply and regulatory services (Supply & Regulatory Support), Target Value Sheets for calibrators/controls, Certification services / training centre Kenya, Regulatory registration support

Materials

Clinical Chemistry, ELISA Tests, Rapid Tests, Haemostasis/Coagulation, Molecular Diagnostics, Autoimmune Diagnostics

Certificates

ISO-certified manufacturing, ISO-Certified Manufacturing

Founded

1972

Employees

ca. 300

Industries

In-vitro Diagnostics (IVD), Medical Engineering/Laboratory Technology, Healthcare, Humanitarian Aid/Global Health

1. 01

   Development & Formulation

2. 02

   Reagent manufacturing (Magdeburg)

3. 03

   Device manufacturing & assembly (LABiTec, Ahrensburg)

4. 04

   Quality control (ISO certified)

5. 05

   Packaging & Labelling

6. 06

   Worldwide delivery & regulatory support

Product Areas & Processes

Locations

Product Groups

Inside the production

Quality

According to the company, HUMAN's manufacturing is ISO certified. Through Target Value Sheets and structured support structures, the quality of calibrators and controls is assured throughout the product life cycle.

History

1. 1972

   Founded in Taunusstein near Wiesbaden as a subsidiary of the Institut Fresenius (Human Gesellschaft für Biotopanalytik und Biotopschutz mbH); development of the first patented test.

2. 1980er

   OEM manufacturing site in Ireland (including for Olympus); first HCG pregnancy test; delivery to over 45 countries; addition of ELISA tests.

3. 1990er

   Launch of the first instrument; introduction of coagulation and laboratory equipment; relocation of headquarters to Wiesbaden.

4. 2000er

   Production site Magdeburg; Olicoo GmbH becomes the new owner; acquisition of IMTEC Immundiagnostika GmbH (autoimmune diagnostics); founding of HUMAN Diagnostics Asia Pacific (Singapore) and HUMAN Diagnostics Middle East (UAE); office in Beijing.

5. 2010er

   Founding of HUMAN Diagnostics Latin America S.A. (Panama Pacifico); acquisition of LABiTec GmbH; office in India; founding of HUMAN Diagnostics Products (Beijing) Co., Ltd.

6. 2020er

   Distribution of SARS-CoV-2 rapid and molecular tests; launch of HumaFIA (first product from Beijing); joint venture with Medsource Ozone Biomedicals Pvt. Ltd. in India; 50th anniversary with around 300 employees.