Professional Manufacturer of Rapid Test Devices
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Newscen Building Office Area Lawn Area
Big Events for Newscen's History
Year of 2003-----
Newscenwas registered in Tianjin Economy Technology Development Area(TEDA) with total registered capital of 25miion US Dollars. In December, Pharmaceutical Manufacture Permit was received from S-FDA.
Year of 2004-----
The product licenses and second grade New Drug Certificate for “Diagnostic Kit for Antibody to HIV(1+2) (Colloidal Gold) " was approved by s-FDA.GMP Certificate for Newscen's production facility was certified by s-FDA. In this year, Newscen was granted by the National Development and Reform Committee (NDRC) as “Model Manufacturing Basis For Biotechnology and Biomedical Engineering" and “Tianjin Significant Industrialization Project of High-technology".
Year of 2005-----
The company's board meeting dismissed the old administrative team and assigned the new general manager and reconstructed the new administrative team.“Constantly Surveying Foreign and Domestic Markets, Aiming At Providing A Variety of Important Products and Taking The Lead At Innovative Technology” had been set as company's operative strategy and“Honesty, verity, authenticity, and innovation", was determined as Newscen's persistent commitment.
Year of 2006-----
Newscen got new HCG, LH License approved by s-FDA ISO13485:2003 and ISO9001:2000 for Newscen's quality control system and CE certificates for HCG and LH were approved by TUV of Germany.
Year of 2007-----
FSH, URS License was approved by s-FDA and the High-Tech Enterprise Certificate was awarded by Science Committee of TEDA. Drug of Abuse test had got the CE Approval. The scientific research project—Nano super-paramagnetic particle was granted by Tianjin Scientific and Technology Committee as key supporting project. At the end of this year, the company re-constructed and switched from state-controlled enterprise into a private-controlled company.
Year of 2008-----
HBsAg, HCV License was approved by s-FDA. The project of Diagnostic Kit for Hepatitis C Virus Antibody was granted by the foundation of small and middleclass enterprises governed by Tianjin Science and Technology Committee.
Year of 2009-----
In the beginning of this year, a new important investor joined Newscen. The development goal has been set for company's next stage:establishment of Newscen Coast Biological Reagent Park and make the company go public in near future. Newscen passed the Nationals-FDA Quality System Evaluation for T Band HIV.
Year of 2010-----
TB Rapid Screen Test, HIV-1/ 2 Gold Rapid Screen Test got the registration certificate for medical device.“AIDS, Hepatitis, Rapid Diagnosis of In Vitro Biological of High-Tech Industrialization Demonstration Projects ” passed state acceptance. The successful development of the first multi-functional, universal“Rapid Immuno Assay Reader" got the registration certificate of medical device from state food and drug administration. ISO13485:2003 and ISO 9001:2000 for Newscen's Rapid Immuno Assay Reader were approved by TUV of Germany. Newscen has been granted by the National Development as “Tianjin Significant Industrialization Project of High-Technology".
Year of 2011-----
Newscen's “Universal Rapid Immuno Assay Reader and rapid test R&D Project "has been listed in “Tianjin Science and Technology Development of Key Enterprises Special Funds" and “The Sixth Batch of Industrialization of Key Projects of Independent Innovation In Tianjin China". Win “Tianjin Science and Technology of Key Enterprises” certificate and the Title of “ 100 Strong Enterprises In Tianjin City of China".
Year of 2012-----
"Quantitative Detection Kit and Reader For Reproductive System Development and Industrialization Project" has been listed in “Tianjin Science and Technology Development of Key Enterprises Special Funds". “Universal Rapid Immuno Assay Reader Project" win “Tianjin Science and Technology Innovation Fund For Key Enterprises". “Y.B.T." win the title of' Tianjin Famous Brand"
Year of 2013-----
"Rapid Immuno Assay Reader and rapid test R&D project" has been listed in “Tianjin Science and Technology Support Plan 2012-2014". CRP, PCT, mALB, TSH quantitative and semi-quantitative test got SFDA.
Contact Person: Mr. Randy.Zhang