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http://www.mbunion.com
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Certificate

Medical Biological Union Group of Companies

The main activity of the Medical Biological Union Group of Companies is to develop and produce diagnostic kits for the detection of infectious diseases, including socially dangerous infections (HIV, etc.). Diagnostic kits have been used in clinical diagnostic laboratories, medical institutions, blood service laboratories, AIDS prevention, and in control centers for more than 25 years.

Medical Biological Union is the third-largest producer of reagent kits in the Russian Federation - more than 15 million tests per year.

Medical Biological Union also develops and produces medical equipment for clinical diagnostic laboratories, automated diagnostic systems, and reagent kits for the quality control of laboratory tests.

Medical Biological Union has the following capacity:

Production facilities; 1,500 m², fully equipped to manufacture diagnostic kits – for more than 2 million tests per month;
Subsidiaries producing reagents and laboratory plastic;
Technical documentation department with extensive experience in the registration of diagnostic reagent kits.
The subsidiary – MBU-Technology LLC which main task is to develop new innovative reagent kits for in-vitro diagnostics. MBU-Technology LLC has great experience in developing reagent kits for the detection of various protein markers in human serum; kits for DNA/RNA isolation and subsequent extraction of specific DNA/RNA molecules by real-time PCR, RT-PCR, LAMP, and ASPCR; kits for measuring hemostasis parameters; control materials for hematology and more.

Licenses and certificates:

License No. ФС-99-04-004923 as of August 02, 2017, to produce and service medical equipment (unless the maintenance is carried out to meet the own needs of a legal entity or individual entrepreneur).

License No. 54.NS.01.001.L.000003.04.15 as of April 28, 2015, to work in the field of the use of pathogens of infectious diseases in humans and animals (unless it is carried out for medical purposes) and genetically modified organisms of III and IV degrees of potential danger carried out in closed systems.

Certificate of conformity of the quality management system ISO 13485: 2016 (EN ISO 13485: 2016) No. 19.0190.026 as of March 01, 2019 in relation to the development, production, storage, and delivery of reagent kits for in vitro diagnostics.

Download General Information here.

History

1992, August 31– MBU was established.

1993 – ELISA manufacturing facility was started up.

1994 – MBU launched HIV test kits on market. For the first time in Russia:

MBU started to manufacture the test kits with color-coded liquid components and color-control of sample addition to the plate wells;

Performance panels of human sera, recognized as the Russian National Immunobiological Standard with specific branch standard number, are developed and manufactured by MBU in joint project with Tarasevich State Institute of Standardization and Control of Medical Biological Preparations and State Research Center of Virology and Biotechnology “Vector”.

MBU started to distribute the test kits on the former USSR, CIS countries markets.

1996 - For the first time in Russia, MBU developed and manufactured the control panels of sera according to FSVOK and Tarasevich SISC requirements specification within the Federal programs on external quality control of laboratories dealing with infectious disease diagnostics and assessment of laboratory performance. MBU started as a prime partner and supplier of Russian Federal System of External Quality Assessment (FSVOK) for such control preparations.

1997 – MBU started to sale its products on international market.

2002 – MBU coupled with the enterprises of Academgorodok and took part in establishment of association “SibAcademInnovation” with the support and assistance of the Siberian branch of RAS and Novosibirsk administration.

2004 - MBU has represented in the USA by Medical Biological Union, LLC.

2005 - MBU test kit for the detection and quantitative determination of IgG antibodies to Measles virus “Measles-IgG-DS” has successfully passed the comparative and evaluation studies in laboratories of WHO network. Since 2005, MBU is permanent participant of Medica fair, Germany. Since 2005, MBU is permanent participant of Medica fair, Germany.

2005 - MBU, Ltd., Russia, and GloBus Consulting Services, Inc., USA, created strategic alliance aimed at expanding products and services offering on Russian and International biotech markets.

2006 – MBU’s QMS was audited and certified according to ISO 9001.

2009 - MBU was one of the first residents of Academpark (Technopark of Novosibirsk Academgorodok).

2013 – MBU’s headquarters moved to new building in Academpark area.

Chronicle and achievements

2001 – MBU was awarded diploma of “100 best Russian Goods” program as a prize-winner of the All-Russian contest.
2003 - MBU has gained "Golden Mercury" National Award in the field of business achievements as "The Best Company in building international innovative cooperation".
2003- MBU was awarded by Head of Novosibirsk region administration with Diploma of First Degree as a winner along with other four winners of “The best development management of innovational activities” competition.
2004 - MBU has gained "Golden Mercury" National Award in the field of business achievements “For the valuable contribution to the development of national entrepreneurship”. The Honor was instituted by Chamber of Commerce and Industry (CCI) of the Russian Federation.
2005 - Krasnoyarsk Regional Center on Preventive Maintenance and Struggle against AIDS and Infectious Diseases granted MBU with the Letter of Gratitude and rewarded with Mark of Public Recognition “NO AIDS” for contribution in counteraction to HIV/AIDS Epidemic expansion in Krasnoyarsk Territory.
MBU became a «Gold Medal» winner in Siberian Fair’ competition within the Innovational Investment Projects Fair, the Siberian Business Forum and 4th International Specialized Exhibition of Business Technologies, Business Infrastructure Development, Novosibirsk, Russia, October 19-21, 2005. Siberian Fair Jury and Head of Novosibirsk region administration rewarded MBU with the “Gold Medal” and prize for the best investment project.
Novosibirsk city administration and Mayor rewarded MBU and its Director for the winning in a competition «The Best small-scale enterprise and entrepreneur of 2005 year" in the nomination "Effectiveness and Development".
2007 - MBU took part in First Siberian Venture Fair, Novosibirsk, and it was rewarded as a winner of Fair Venture Projects competition in the nomination “Best Marketing”.
2009 - MBU took part in the competition «The Best small-scale enterprise and entrepreneur of the year - 2009" arranged by Novosibirsk city administration. A company and its Director were rewarded as the winners in the nomination "Innovation Business".
2010 - Novosibirsk city administration has recorded MBU company on Novosibirsk city’s “Board of Honour” for the weighty contribution in socio-economic development of the city.
2010 - MBU was rewarded with Diploma as a 1’st place winner in the nomination «The Best exporter - entity of small and medium- sized enterprise" and with 2’nd place Diploma, nomination «The Best entity of small and medium-sized enterprise in Innovations" within competition’s frame announced by the Ministry of Industry, Trade and Business.
2011 - MBU was rewarded as a winner within competition "Best entity of small and medium-sized enterprise of Novosibirsk region“: with Diploma as a 1’st place winner, «The Best exporter - entity of small and medium-sized enterprise" and with 2’nd place Diploma of «The Best entity of small and medium-sized enterprise in Innovations“.
2011 - MBU was rewarded as a 1’st Grade winner of National Award "Golden Mercury", nomination "The Best Enterprise-exporter in the field of international innovative cooperation“ announced by Chamber of Commerce and Industry (CCI) of the Russian Federation.

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