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 ¹ 4047.32.01/0
of 23.05.2006;
- Certificate ¹ 4047.21.01/0 of
23.05.2006;
- Certificate ¹ 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 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
ELISAThe 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.
Company
