Company History
An enterprise «Diaproph» was
found in 1991 at the basis of Gromashevsky Research Development
Institute of Epidemiology & Infectious diseases - the
scientific research centre of Ukraine dealing with problems of control
of infectious diseases. The main activities of Diaproph were to
establish, development and production of the state-of-the art
diagnostic kits for detection of the most actual infectious diseases.
In 1996 the enterprise was reorganized into a scientific industrial
enterprise «Diaproph-Ìed».
The scientific industrial enterprise
«Diaproph-Med» is a modern immunobiotechnological company
specializing on development and production of test kits based on
enzymelinked immunosorbent assay (ELISA) method for diagnostics of
different human and animal infectious diseases.
The continuous research, technology
improvement, highly skilled personnel and production and technical base
allowed the company to realize a complete cycle of production and
release of quality in vitro diagnostic devices meeting customer’s
demands.
Main directions of activities:
- Research and development of diagnostic
test kits and their components based on genetic engineering, hybridome
and other modern technologies
- Production of ELISA test kits, biological
and chemical reagents (purified native and recombinant proteins,
monoclonal and polyclonal antibodies, HRP conjugates, chromogens,
affine sorbets etc.)
- Servicing and technical support of diagnostic laboratories, trainings and seminars
- Consulting for the good laboratory practice and the development of quality system for laboratory diagnostics
- Technology transferring
- Support of social projects
Quality Management System
The high technological discipline, control system established at
all stages, availability of exact interactions in processes of
production, sales and product servicing allowed company’s team in
2001 to elaborate and introduce the quality management system (QMS)
according to ISO 9001:2004 standard (certificate). In 2004 Bureau Veritas Quality
International recertified the QMS according to ISO 9001:2000 standard
(the certificate ¹154268 issued at 04.05.2004). Since 2003 the company
have become oriented on harmonization with EU legislative norms. The
main normative European document that regulates activities relating to
IVD production is Directive 98/79/EC. Considering that Diaproph-Med
developed and implemented additional requirements for manufacturer of
IVDs in accordance with ISO 13485:2003 (certificate) that is harmonized standard to
IVDD. The company have begun the process of CE confirming for own
products and first product that is subject of process for EC
declaration of conformity is DIA-HIV ½.
Company
