About NewScen
Company Profile
Manufacturer: NewScen Coast Bio-Pharmaceutical Co., Ltd. ( NEWSCEN )
Company History: Founded in 2003, 20 Years Experience in the IVD Industry
Site of Headquarter: Base in ( TEDA ) Tianjin, the Largest Port City in North China
Management System: ISO 9001: 2015 , ISO 13485: 2016
OEM for Uncut Sheet: OEM Service of Uncut Sheet for Rapid Diagnostic Test Kits
( Lateral Flow Assay / Colloidal Gold Method )
Uncut Sheet Category :
Including 57 Kinds of Uncut Sheet in 10 Categories
- Infectious Disease Test Uncut Sheet ( STD Included )
- Tropical Disease Test Uncut Sheet
- Drug of Abuse Test Uncut Sheet
- Tumor Marker Test Uncut Sheet
- Respiratory Disease Test Uncut Sheet
- Hormone Test Uncut Sheet
- Iron Deficiency Test Uncut Sheet
- Cardiac Marker Test Uncut Sheet
- Inflammatory Marker Test Uncut Sheet
- Renal Injury Test Uncut Sheet
Global Market: 90+ Countries and Regions Globally
Founded in 2003, Tianjin, China, NewScen Coast Bio-Pharmaceutical Co., Ltd. ( NEWSCEN ) has been specializing in the R & D, production and promotion of rapid diagnostic test kits and lateral flow assay uncut sheets over decades. As a professional manufacturer in the IVD industry, NEWSCEN is well-known for providing the finished and semi-finished products as well as OEM services in a comprehensive category, including infectious disease, tropical ( mosquito transmitted ) disease, drugs of abuse, tumor marker, hormone, etc.
Our R & D team of excellence is dedicated to the continuous research, development and improvement of rapid diagnostic test kits products that satisfy the evolving trends of the global healthcare industry. The manufacturing workshops are equipped with highly-automated equipments and facilities and staffed by experienced professionals. The triple quality control procedures are strictly followed in accordance with the management system of ISO 13485 and ISO 9001 in daily operation to meet the highest standards of product quality.
In addition to the POCT finished products and services for end-users, we treasure and focus on the long-term cooperation with enterprise-level clients ( i.e., distributors and manufacturers ) for OEM services, e.g., semi-finished products such as lateral flow assay uncut sheets. NEWSCEN is fully competent to fulfill and deliver orders of different sizes worldwide, e.g., from large-scale order of million pcs level to small-scale trial order for preliminary clinical evaluation, by the utilizing of our powerful and efficient production capacity as well as the flexible and scientific production arrangement.
The competitive rapid test products of NEWSCEN have been widely used in domestic and foreign hospitals, diagnostic laboratories, community clinics and self-testing at homes with a recognized reputation for the convenience, accuracy and reliability. We are more than proud to be at the forefront of the IVD industry and looking forward to provide high-quality products to our clients globally. Together we share, smarter we cheer. Choose NEWSCEN, and enjoy the superior experiences of tailored solutions exceeding typical OEM cooperations.
NewScen History
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2002 National New Drug Certificate for HIV RDTs ( CLASS II )
- 2008 A Leading Reformation for Testing Method: the Application of Double Antigen Sandwich Method for HCV RDTs
- 2010Innovation & Production of the Rapid Immuno Assay Reader ( Open System with Universal Compatibility )
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2012Innovation & Production of the Quantitative Colloidal Gold Rapid Test Kits
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2014Establishment of the Managed Integrated POCT ( MI-POCT ) System Based on the Internet+ Technology
- 2016Proposal & Promotion of the Portable MI-POCT Diagnosis & Treatment Platform for Primary Care Physicians
- 2016Technology Transfer of the Cutting-edge Microfluidic Immunofluorescence Testing Technology
- 2017 Listed in the NEEQ Company Name: NewScen Coast Bio-Pharmaceutical Co., Ltd.
- 2019Establishment & Completion of the First Automatic,Intelligent & Open-ended Microfluidic Immunofluorescence Platform in China
- 2020Global Certification of Medical Devices, Including CE Certificates, FDA Certificates of Australia ( TGA ), Brazil ( ANVISA ), Dominica, etc. of the COVID-19 Antigen & COVID-19 IgG/IgM Microfluidic Chip & RDTs Respectively
- 2021Global Certification of Medical Devices, Including CE Certificates & Vietnam FDA Certificates of the COVID-19 Neutralizing Antibody Microfluidic Chip & RDTs Respectively
- 2022Global Certification of Medical Devices, Including CE Certificates of 18 Products, Thai FDA Certificate for HIV RDTs, China NMPA Certificate for Rapid Immuno Assay Reader NS7001 BRDI ( CLASS II )
Global Business
NEWSCEN products and services are prevalent in the global market, covering more than 90 countries and regions worldwide, including Europe, Southeast Asia, Middle East, North and South America, Africa, Australia.