Development, manufacture and distribution of in-vitro diagnostics, ELISA test kits and medical equipment
bioactiva diagnostica GmbH
Bad Homburg v. d. HöheNew on Amplifa
About bioactiva diagnostica
bioactiva diagnostica GmbH was founded in 2001 in Frankfurt am Main and has been based in Bad Homburg v. d. Höhe since 2004. The company manufactures in-vitro diagnostics, including ELISA test kits (e.g. for toxoplasmosis, rubella, CMV and chlamydia), as well as products based on molecular-biological and immunological methods and selective media for pathogen detection. In addition, bioactiva distributes medical equipment such as blood pressure monitors, otoscopes, stethoscopes, endoscopy equipment, patient monitoring systems, portable X-ray devices and dental chairs. The portfolio comprises more than 2,000 products. Complemented by logistics, customs clearance, shipping, and medical consulting and support for research laboratories and institutions, the company offers a complete solution from a single source. Cooperation partners are Biocore (diagnostic tests) and Lionex (molecular diagnostics and therapeutics); worldwide, the company works with more than 80 distributors. Quality assurance is carried out in accordance with EN ISO 13485.
- Site
- Bad Homburg v. d. Höhe
- Processes
- Manufacture and distribution of ELISA test kits (e.g. Toxoplasma, Rubella, CMV, Chlamydia), Manufacture of in-vitro diagnostics using molecular-biological and immunological methods, Distribution of medical equipment (blood pressure monitors, otoscopes, ophthalmoscopes,, Logistics, Customs clearance, Shipping, Medical consulting and support for research laboratories and institutions
- Materials
- ELISA Test Kits, Molecular and Immunodiagnostics
- Certificates
- EN ISO 13485, EC Certificate (IVD Directive 98/79/EC, Annex IV)
- Founded
- 2001
- Industries
- In-vitro diagnostics (IVD), Molecular diagnostics, Medical technology, Laboratory supplies
- 01
Development and manufacture of in-vitro diagnostics (ELISA test kits,
- 02
Distribution of medical equipment
- 03
Logistics and customs clearance
- 04
Shipping
- 05
Medical consulting and support
Products & Methods
ELISA Test Kits
Test kits for the determination of Toxoplasma, Rubella, CMV and Chlamydia in accordance with the IVD Directive 98/79/EC.
Molecular and Immunodiagnostics
Manufacture of in-vitro diagnostics using molecular-biological and immunological methods and selective media for pathogen detection.
Locations
Bad Homburg v. d. Höhe
DEHeadquarters, manufacturing and distribution
- Materials
- ELISA test kits, in-vitro diagnostics, medical equipment
Industries
Processes & technical limits
| Processes | Tolerance | Max. part | Weight | Lot size | Materials |
|---|---|---|---|---|---|
| Manufacture and distribution of ELISA test kits (e.g. Toxoplasma, Rubella, CMV, Chlamydia)Testing | – | – | – | – | – |
| Manufacture of in-vitro diagnostics using molecular-biological and immunological methodsTesting | – | – | – | – | – |
| Distribution of medical equipment (blood pressure monitors, otoscopes, ophthalmoscopes,Assembly | – | – | – | – | – |
Additional services
Reference customers
Quality & Certification
The quality management system fulfils the requirements of EN ISO 13485; all products are CE-certified. An EC certificate in accordance with Annex IV of the IVD Directive 98/79/EC (excluding Sections 4 and 6) confirms the quality system for design, manufacture and final inspection, audited by mdc.
| Evidence | Bad Homburg v. d. Höhe |
|---|---|
| EN ISO 13485 | |
| EC Certificate (IVD Directive 98/79/EC, Annex IV) |
History
- 2001
Founded in Frankfurt am Main; initially supplying raw materials for R&D to German IVD companies
- 2004
Relocation to Bad Homburg; expansion of products and services in the field of healthcare & medicine; first markets in the Middle East and Europe
- 2010
Partnership with Biocore, a company for diagnostic tests
- 2018
Partnership with Lionex, a company for molecular diagnostics and therapeutics
- 2021
20th company anniversary