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In Vitro Diagnostic Services
33 services found
Manufactured by:Prestige Diagnostics U.K. Ltd. based inGalgorm, NORTHERN IRELAND
Simple, rapid and reliable, our Agglutination range includes assays for Syphilis, Febrile Antigens (WIDAL) and for Latex Serology. These reagents are designed to give maximum shelf ...
Manufactured by:Prestige Diagnostics U.K. Ltd. based inGalgorm, NORTHERN IRELAND
We know preformance is paramount. Prestige Diagnostics offers only the highest quality ABO & RhD Blood Grouping Reagents to meet the needs of blood banks, clinics, hospital laboratories and transfusion centres across the ...
Manufactured by:Prestige Diagnostics U.K. Ltd. based inGalgorm, NORTHERN IRELAND
Recognised internationally for their quality, Prestige Diagnostics Clinical Chemistry Reagents are compatible with most semi-automated and fully-automated analysers. Utilising colorimetric, UV and turbidimetric methods, we continuing to source the best raw materials available. Our kits maintain the highest standards and provide the utmost convenience in the ...
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 ...
Manufactured by:in.vent Diagnostica GmbH based inBerlin, GERMANY
With our research & development department we contribute to the development of high-quality in-vitro diagnostics and support our partners with products and qualified ...
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 ...
Manufactured by:ORGENTEC Diagnostika GmbH is part of the Sebia Group based inMainz, GERMANY
Our in vitro diagnostic medical devices (IVD) are CE marked. Our quality management system is certified according to ISO 13485 in the latest ...
by:Stratec Se based inBirkenfeld, GERMANY
STRATEC is a reliable partner and one-stop provider of end-to-end automation solutions in the fields of in-vitro diagnostics and life sciences. Our capabilities, technology and processes span the entire value chain of new product creation. We offer comprehensive solutions from a single source that may include complex consumables, instrumentation and software. ...
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 ...
by:European Device Solutions Limited based inWhitley Bay, UNITED KINGDOM
We are a leading supplier of Software Quality Assurance and Regulatory Advice to industry and academia with many years’ experience in FDA, EMA, & MHRA regulated life sciences industries in the UK, Ireland, US, Far East and the EU. Our services include the following devices: Medical devices (and accessories), In-vitro diagnostic devices (and ...
Manufactured by:Visia Lab Srl based inSan Giovanni Valdarno, ITALY
VISIA LAB designs, engineers and manufactures hardware and software solutions for clinical diagnostics with a specific focus on applications of immunometry, immunofluorescence and autoimmunity, digital pathology and cytogenetics, cytodiagnostics and liquid-handling. Founded in 2020 from a spin-off of VISIA Imaging Srl, VISIA LAB has inherited constant growth over the years thanks ...
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 ...
by:Linear Diagnostics Limited based inBirmingham, UNITED KINGDOM
Initially focused on sexually transmitted infections, the technology can be utilised in a wide range of diagnostic applications. Based on market opportunity, Linear Diagnostics concluded that a dual test for Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG) would present the best initial application for linear ...
Manufactured by:Eurotest Laboratori S.r.l. based inBrugine, ITALY
All devices sold in the European Union must comply with the relevant product directives and have CE ...
Manufactured by:Visia Lab Srl based inSan Giovanni Valdarno, ITALY
Our product design and development services provide our customers with a single point of responsibility throughout the entire product making process. ...
Manufactured by:Visia Lab Srl based inSan Giovanni Valdarno, ITALY
Our product design and development services provide our customers with a single point of responsibility throughout the entire product making process. Based on the foundation of ISO 13485 for IVD medical devices, our manufacturing team offers flexibility, expertise in laboratory diagnostics and device manufacturing inspired by the best quality standards. We have a long experience in manufacturing ...