JSC Diaproph-Med

ABOUT COMPANY

NEWS

Medica 2009 [06.10.2009]

We invite you to visit us 18 - 21 November at Medica 2009, Dusseldorf, booth J19, hall 3. We will be pleased to welcome You there.

Leader of the National Business Rating [22.04.2008]

Our Company entered in the number of leaders of the National Business Rating in the field of the "Chemical production"

Medica 2007 [11.10.2007]

We invite you to visit us 14 - 17 November at Medica 2007, Dusseldorf, booth J19, hall3. We will be pleased to welcome You there.

ANNOUNCEMENT [06.06.2007]

DIA-HIV 1/2 bearing CE-mark, lot No. 086-07 is approved for commercializaion in EU market by Notified Body (MDC GmbH, Germany) according to Directive 98/79/EC, Annex IV.6. Contact us for orders.

CE-certification of the Product DIA-Trep according to IVD-regulations in European Union [07.05.2007]

The company Diaproph-Med successfully passed the annual surveillance audit conducted by Notified Bodies (MDC GmbH, EuroCAT GmbH, Paul-Ehrlich-Institute, Germany) in May, 7 2007 according to requirements of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices and of EN ISO 13485:2000 “Medical devices - Quality management systems - Requirements for regulatory purposes”. The audit was conducted for the purposes of conformation the following:

- CE-certificate № 4047.32.01/0 of 23.05.2006;

- Certificate № 4047.21.01/0 of 23.05.2006;

- Certificate № 4047.48.01/0 of 23.05.2006

Within the surveillance audit the test kit DIA-Trep intended for the detection of antibodies to T.pallidum was applied for CE-mark and the examination of Technical documentation for DIA-Trep kit was successfully held. The kit DIA-Trep was recommended for use and commercialization in EU market.

The technology for the production of high purified recombinant interferon [03.03.2007]

At the enterprise JSK “Diaproph-Med” the technology for the production of high purified recombinant interferon from E.coli biomass of gene modified bacteria, in the genome of which there is build the sequence of alpha-2b human interferon gene. It is typical for recombinant alpha interferons immunomodulating, antiviral and antitumor activity. There is at the enterprise the preparation “Diaferon-B” is designed and produced for use in the veterinary medicine on the basis of obtained substance of recombinant interferon. The preparation has been successfully tested and registered in Ukraine (registration certificate #2149-04-0249-06 from October 20, 2006).

ANNOUNCEMENT [16.10.2006]

DIA-HIV 1/2 bearing CE-mark, lot No. 064-06 approved for commercializaion in EU market by Notified Body (MDC GmbH, Germany) according to Directive 98/79/EC, Annex IV.6. Contact us for orders.

CONTRADICTION [15.09.2006]

For the purposes of confutation of information extended by Russian competitors in mass media relating to prohibition of use in medical establishments of the Russian Federation of enzyme immunoassay for the detection of antibodies to HIV 1 and 2 manufactured by Diaproph-Med, We declare...

CE-certification of the Product DIA-HIV ½ and Certification of Quality Management System of Diaproph-Med according to IVD-regulations in European Union [April 2006]

The certification process at Joint-stock company Diaproph-Med was successfully accomplished by Notified Bodies (MDC GmbH, EuroCAT GmbH, Paul-Ehrlich-Institute, Germany) in April 2006 according to the following subjects:

- The compliance of Quality Management System of Diaproph-Med with EN ISO 13485:2000 “Medical devices - Quality management systems - Requirements for regulatory purposes” (Certificate No. 4047.48.01/0) and Annex IV – Section 3 of Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices (Certificate No. 4047.21.01/0). The scope of certification covers research, development and production of in vitro diagnostic test kits and reagents for laboratory diagnostics: devices and systems for HIV diagnostics.

- The compliance with requirements of Council Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices and Common Technical Specifications (CTS) for in vitro-diagnostic medical devices (Commission Decision of 7 May 2002 – 2002/364/EC) for the quality of DIA-HIV ½ ELISA. The obtained certificates entitle to place the test kit DIA-HIV ½ manufactured by JSC Diaproph-Med in European Union market of IVD for sale and use. kit intended for the diagnostics of HIV infection. That is entitled to label the DIA-HIV ½ with CE-sign (CE-Certificate No. 4047.32.01/0).
During the certification process the extensive services has been done as follow:
- The external evaluation of quality of the DIA-HIV ½ kit on the basis of Paul-Ehrlich-Institute (German Health Authority for Sera and vaccines) on behalf of MDC GmbH (

Germany

) (for detail please download here). Results of the complete history evaluation you can see here.
- The examination of Technical Documentation for DIA-HIV ½.
- The examination of the Quality Manual of JSC Diaproph-Med.
- The external certification audit at the plant of JSC Diaproph-Med by auditors from MDC GmbH, EuroCAT GmbH and Paul-Ehrlich-Institute (

Germany

). The examination of documentation of quality management system, the inspection of all departments of the company, the evaluation of all process including the development, the production, the control and quality assurance of DIA-HIV ½ were conducted during the audit.
At the time of the preparation to the certification audit, the respective Harmonized Norms to the Directive 98/79/EC and NB Recommendations were applied to Quality Management System of the company (19 European Harmonized Norms).
The obtained certificates entitle to place the test kit DIA-HIV ½ manufactured by JSC Diaproph-Med in European Union market of IVD for sale and use.

The test kit for diagnostics of H5N1 avian influenza A virus [29.03.2006]
The test kit «DIA-Real Avian Influenza» for the detection of viral RNA of Н5N1 avian influenza А virus in clinical materials of poultry with the method of one-stage Real - Time RT-PCR was elaborated on the basis of JSC Diaproph-Med in collaboration with Government enterprise «STCImmunobiotechnology STC «Institute of Monocrystal» of National Academy of Sciences of Ukraine and Institute of Veterinary Medicine UAAS. in detail

JSC "Diaproph-Med" has received the certificate of quality ISO 9001:2000 [21.05.2004]

JSC «Diaproph-Med» obtained the certificate № 154268 for quality Management System in accordance with ISO 9001:2000 issued by BVQI.

COMPANY MAIN AIMS ARE :

to Guarantee safety, stable and high quality of our products in accordance with customer’s expectations, established and legislative requirements.
to Retain and consolidate own leadership in the market and achieve stable image in new markets owing to product diversification, high quality of supplied products, recognition of customers' requirements, improving product servicing.