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In Vitro Diagnostic Services In Usa
14 services found
Manufactured by:More Diagnostics Inc. based inLos Osos, CALIFORNIA (USA)
More Diagnostics is your In Vitro Diagnostics Manufacturing Partner. As a manufacturer of in vitro diagnostic products, we strive to deliver the highest quality materials to you and your customers. Our breadth of experience in the IVD manufacturing market helps us to control fixed costs, enables efficient use of ...
Manufactured by:Veracyte, Inc. based inSouth San Francisco, CALIFORNIA (USA)
Veracyte offers a complete range of in vitro diagnostic (IVD) and companion diagnostic development services to biopharmaceutical companies and diagnostic companies. Our manufacturing site is located in our European headquarters and Veracyte provides full life cycle management ...
by:BSI Consulting based inHerndon, VIRGINIA (USA)
BSI Compliance Navigator is the smart, simple way to manage your regulatory information for Medical Device and In Vitro Diagnostic products with EU, UK and US requirements – helping you to get to market faster and maximize your ...
by:Chemical Inspection & Regulation Service Limited (CIRS) based inHangzhou, CHINA
Medical Devices and In Vitro Diagnostics Product Regulatory Compliance in China. Pre-market Investigation & Analysis. Medical Devices Registration & Approval. Clinical Trial Consulting. Manufacturing and Distributing License Approval. Quality Assurance & Compliance. ...
by:STEMart based inShirley, CALIFORNIA (USA)
CE marking is the manufacturer's declaration that their product complies technically and administratively with the essential regulatory requirements of Medical Device Directive 93/42/EEC (MDD) and its supplementary Directive 2007/47/EEC, Active Implantable Medical Devices Directive 90/385/EEC (AIMDD) and In Vitro Diagnostics Directive (IVDD) 98/79/EC, which ...
Manufactured by:KSL Biomedical based inBuffalo, NEW YORK (USA)
KSL CRO Services team are well versed in quality compliance including requirements from ISO 13485:2016, 21 CFR Part 820 Quality System Regulation (QSR) and In Vitro Diagnostic Regulation (IVDR). KSL's team provides quality compliance services for start-ups and well-established companies looking to build out Quality Management System (QMS), maintain and improve ...
Manufactured by:KSL Biomedical based inBuffalo, NEW YORK (USA)
KSL Biomedical, Inc. (“KSL”) was founded to deliver innovative diagnostics and therapeutics. KSL has professionals with many decades of experience in US and international regulatory compliance, product design and development, clinical trials, and protection of intellectual property to work with health care industry partners to address their need for special resources ...
Manufactured by:Nova Biomedical based inWaltham, MASSACHUSETTS (USA)
Nova Biomedical is a world leader in the development and manufacturing of advanced technology blood testing analyzers and diagnostic products. As the largest privately held in vitro diagnostic company in the U.S., we employ over 1,200 people, including over 125 scientists and engineers, and have sales and service subsidiaries in nine countries ...
Manufactured by:Shenzhen AIVD Biotechnology Co. , LTD. based inCheektowaga, NEW YORK (USA)
AIVD Biotech has established three R&D divisions: IVD Raw Materials, Immunodiagnostic and Molecular Diagnostic Test ...
Manufactured by:Avioq, Inc. based inResearch Triangle Park, NORTH CAROLINA (USA)
Avioq, a trusted clinical diagnostics company, has developed a broad line of diagnostics in-vitro assays for the clinical lab. With this experience, we offer extensive contract development and manufacturing ...
Manufactured by:Owlstone Medical Ltd. based inCambridge, UNITED KINGDOM
Developing Breath Biopsy for clinical applications in early detection and precision ...
Manufactured by:Avioq, Inc. based inResearch Triangle Park, NORTH CAROLINA (USA)
Our development process is the fastest and most streamlined system to get your IVD project through our proven Quality System, manufactured, approved and to market. We have a highly experienced team of scientists, project managers, regulatory and quality staff that have a long history of successful implementation of complex IVD development projects. By using a nimble cross-functional team ...
Manufactured by:Alfa Scientific Designs, Inc based inPoway, CALIFORNIA (USA)
ALFA offers development services to include contract product development. technology transfer, and various technological offerings such as latex, lateral flow, and fluorescent methodologies. ALFA develops breakthrough designs produced to the highest quality standards and provides a complete solution for customer specific design, assay development, laboratory and clinical sample testing. ...
Manufactured by:Getein Biotechnology Co.,Ltd. based inNanjing, CHINA
Getein Biotech Inc. has a high-quality research and development team of “key medical talents”, with strong technical and R&D advantages. At present, there are nearly 300 professionals engaged in high-tech research and development, and more than 40 people with middle and high level titles, and more than 87% are undergraduate or above degree. For this reason, the company has been ...