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MEDICHEM Diagnostica GmbH & Co. KG
MEDICHEM has access to an experience of more than 20 years in development and production of In-Vitro-Diagnostica. The office is located in Steinenbronn, close to the Stuttgart Airport. The quality management system of MEDICHEM Diagnostica GmbH & Co. KG is certified according to EN ISO 9001 and EN ISO 13485.
The foundation of MEDICHEM Diagnostica has been made by Atou Khalide Lô in 1986. At that time it was a sole proprietorship. In 1998 his son Insa Lô joined the company as a partner, he finally became managing director in 2004. Now, MEDI-CHEM Diagnostica employs 14 permanent workers and additionally several freelancers in research and development affairs.
MEDICHEM provides reference material for internal accuracy and precision testing. Precision testing focuses mainly on the longitudinal expansion of the single control test within the quality control batch, i.e. a specific concentration range next to legal or generally applicable boundary values. Materials for precision testing do not necessarily have to be part of proficiency tests but they must not be used of accuracy testing.
Accuracy testing materials are additionally used to review the compliance level of the individual measurement result with the real value of the indicator. The compliance level has to be evaluated trustworthy by a minimum of representative testings with validated, mostly internal standardized and evident methods, especially proficiency tests.
For internal accuracy testing MEDICHEM provides both accuracy test samples as well as selected proficiency test samples, taken from proficiency tests for well-known professional medical associations i.e. DGKL (German Society for Clinical Chemistry and Laboratory Medicine) or GTFCh (Society of Toxicological and Forensic Chemis-try). This happens after the evaluation of the respective proficiency test and the suc-cessive result approval of the proficiency test authority. Those proficiency tests can therefore be used as reference test samples, currently the reference material most suitable and characterized best for forensic-toxicological analyses.
Biotech Companies, Medtech Companies, In-vitro Diagnostics, Analytics, Contract Manufacturing/OEM, Diagnostics, Laboratory Supplies/Reagents