MBS NEW S.R.L. - Medical Biological Service Milan, Italy - since 1972
IMMUNO-CHEMISTRY RESEARCH
For over 30 years MBS NEW S.R.L. Medical Biological Service is manifacturing ELISA tests for Hepatitis A\B\C\D\E and Retroviruses for HIV & Corona Virus. In fact the main activity of the Company is connected with the development, the manufacture and the marketing of immunodiagnostic Hepatitis and Retrovirus kits in ELISA microplate with breakable wells.
All the most important strategic materials are studied, developed, characterized and validated by MBS NEW laboratory. Monoclonal antibodies, synthetic peptides, recombinant proteins and highly purified HRP conjugates provide the assays with the best tools for the manufacture of high quality products.
The R&D Department projects are focused to the continuous updating of the kits and to the development of new products in accordance to the market requests.
The last invention is the Pantest, Ref. 1080KS. An Elisa kit able to detect simultaneously, in a single well, 4 parameters: HCV, HIVAg/Ab and Syphilis. The product has been already CE marked.
MBS NEW works according to certifications
ISO 13485:2016
and
EC IVD
(Production Quality Assurance System for medical devices )
manufacturing and final inspection covered by Annex II, List A, on the products based on immunoenzymatic methodology, in the scope on HIV and Hepatitis, that complies with the requirements of the Directive 98/79/EC, Annex II - legislative Decree (D. lgs.) no. 332/2000.
The kits are sold in the national and in the international market with MBS NEW mark and, on OEM basis, conveyed to some important diagnostic Companies to be sold with their trade marks. In this case the products can be supplied in different formats as bulk, as semi-bulk or in other possible ways. A simple but efficient organization allows MBS NEW to meet the needs of the customers for a flexible, end-user oriented full service in immunodiagnostic.
The Company is very interested in developing the activity and in a possible co-operation with other Companies in the world-wide market, also for the transfer of technology (know-how).
All the most important strategic materials are studied, developed, characterized and validated by MBS NEW laboratory. Monoclonal antibodies, synthetic peptides, recombinant proteins and highly purified HRP conjugates provide the assays with the best tools for the manufacture of high quality products.
The R&D Department projects are focused to the continuous updating of the kits and to the development of new products in accordance to the market requests.
The last invention is the Pantest, Ref. 1080KS. An Elisa kit able to detect simultaneously, in a single well, 4 parameters: HCV, HIVAg/Ab and Syphilis. The product has been already CE marked.
The Company works according to the certifications IS0 9001: 2008 and ISO 13485:2012 and also MBS NEW has already obtained from ITC - Notify Body No.1023 - the EC Certificates for Production Quality Assurance System for medical devices (IVD), the CE Mark for design, manufacturing and final inspection covered by Annex II, List A, on the products based on immunoenzymatic methodology, in the scope on HIV and Hepatitis, that complies with the requirements of the Directive 98/79/EC, Annex IV
The kits are sold in the national and in the international market with MBS NEW mark and, on OEM basis, conveyed to some important diagnostic Companies to be sold with their trade marks. In this case the products can be supplied in different formats as bulk, as semi-bulk or in other possible ways. A simple but efficient organization allows MBS NEW to meet the needs of the customers for a flexible, end-user oriented full service in immunodiagnostic.
The Company is very interested in developing the activity and in a possible co-operation with other Companies in the world-wide market, also for the transfer of technology (know-how).