Development, manufacturing and distribution of in-vitro diagnostics, reference materials and reagents for toxicology and clinical chemistry
MEDICHEM Diagnostica GmbH
71144 SteinenbronnNew on Amplifa
About MEDICHEM
MEDICHEM Diagnostica GmbH is a developer, manufacturer and distributor of in-vitro diagnostics based in Steinenbronn near Stuttgart. The company initially focused on the development and manufacture of clinical chemistry reagents; from 1989 onwards, and in close cooperation with institutes of forensic medicine and medical laboratories, the development of reference materials was added. Under the Medidrug® brand, the company offers control materials and calibrators for quality control of toxicological and forensic analyses, including alcohol, alcohol consumption markers, barbiturates, benzodiazepines, narcotics and drug-of-abuse screenings as well as blank matrices. The reference materials are produced on the basis of human matrices (serum, whole blood, urine, hair) and are available as ready-to-use solutions, lyophilisates, powders and 1-mm hair sections in ampoules and vials. The target values of the products are determined by independent accredited laboratories. Customers are toxicological and forensic institutes and laboratories in Germany and abroad; documents and website are also available in English.
- Site
- Steinenbronn
- Processes
- Development, manufacturing and distribution of in-vitro diagnostics, Reference materials for quality control of toxicological and forensic analyses
- Materials
- Human Serum Matrix, Human Whole Blood, Urine Matrix, Hair Matrix, Lyophilisate, Powder
- Certificates
- ISO 9001:2015, ISO 13485:2016, ISO 9001, ISO 13485, EU Directive 98/79/EC (IVD)
- Founded
- 1986
- Industries
- Toxicology, Forensic Medicine, Medical Laboratories, Clinical Chemistry
- 01
Development
- 02
Manufacturing
- 03
Quality control and analysis certificates
- 04
Distribution
Matrices and Product Forms
Human Serum Matrix
Basis of ready-to-use liquid reference materials, e.g. ethanol and concomitant substance controls; minimizes matrix effects.
Human Whole Blood
Matrix for ethanol and alcohol whole blood controls for GC analysis.
Urine Matrix
Basis for controls of drug-of-abuse and confirmatory analysis in urine.
Hair Matrix
Hair reference materials as 1-mm sections with verified values, e.g. ethyl glucuronide and DOA.
Lyophilisate
Freeze-dried control materials with long shelf life, ready to reconstitute.
Powder
Pure reference substances, e.g. ethyl glucuronide, filled in milligram quantities.
Site
Steinenbronn
DEDevelopment, Manufacturing and Distribution
- Lot size
- Batches (lots) with analysis certificate
- Materials
- Human matrices (serum, whole blood, urine, hair)
Product Groups
Inside the production
Industries
Additional services
Quality and Certification
The quality management system is certified according to DIN EN ISO 9001:2015 and DIN EN ISO 13485:2016 (certificate no. 492175); the products comply with EU Directive 98/79/EC. Target values of the reference materials are determined by independent accredited laboratories.
| Evidence | Steinenbronn |
|---|---|
| ISO 9001 | |
| ISO 13485 | |
| EU Directive 98/79/EC (IVD) |
Company History
- 1986
Founded as a sole proprietorship by Atou Khalide Lô; focus on the development and manufacture of clinical chemistry reagents
- 1989
Start of the development of reference materials in cooperation with institutes of forensic medicine and medical laboratories
- 1998
Insa Lô joins the company as a partner after eight years of employment
- 2004
Insa Lô takes over the management
- 2007
First issue of the ISO-13485 certificate (12.02.2007)