Profiles of IFCC Corporate Members
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Abbott is a global, broad-based health care company devoted to the discovery, development, manufacturing and marketing of pharmaceuticals and medical products, including nutritionals, devices and diagnostics. The company employs nearly 90,000 people and markets its products in more than 130 countries. Abbott Diagnostics is a global leader in in vitro diagnostics and offers a broad range of innovative instrument systems and tests for hospitals, reference labs, molecular labs, blood banks, physician offices and clinics. Abbott's diagnostic solutions offer customers automation, convenience, bedside testing, cost effectiveness and flexibility.
ADx NeuroSciences is a R&D company committed to improving the diagnosis of Alzheimer's disease & dementia. The company identifies and develops novel biomarkers for accurate diagnosis and the effective treatment and follow-up of patients suffering from Alzheimer's, Parkinson's and other neurodegenerative diseases.
Agappe Diagnostics Ltd.
Manufacturers of complete range Diagnostic Reagents like Biochemistry kits, Serology, Immuno Turbidometry, Coagulation, Hematology Reagents and system packs for Biolis series. Products carry CE Marking. ISO 9001-2008 and 13485 - 2003 certified company. Also deals in a range of Fully Auto and Semi Auto Analyzers for various applications. We are exclusive distributors for world famous brands Like Tokyo Boeki Biolis Series and Mindray.
Web site: www.agappe.com
Analis R&D Diag
For more than 25 years, the "ANALIS R&D Diag", group specialized in electrophoresis, has developed kits for in vitro diagnostic, which have been distributed throughout the world. As a result of our long experience in designing kits for electrophoresis using agarose gels, Analis has developed kits for Capillary Electrophoresis. CEofix™ kits for Capillary Electrophoresis presented here are for Clinical Routine as well as Clinical Research:
- Carbohydrate Deficient Transferrin kit is used to detect AUD (alcohol use disorder). The same kit has been used for Congenital Disorder of Glycosylation (CDG) and for transferrin in Cerebrospinal Fluid (CSF). This kit is FDA device listed and has CE-IVD label for Europe.
- Hemoglobin analysis including variant analysis is possible using two buffer systems (alkaline and basic). The hemoglobin kits are CE-IVD labeled for Europe.
- More generic buffers are also available which allow analysis of proteins for example in CSF or for peptides such as glutathione (GSH-GSSG) in blood.
- Anions, organic acids or cations may also be analyzed using specific applications.
- And a special dynamic coating may be used to facilitate CE-MS applications for proteome biomarker.
"R&D Diag" is composed of highly trained people, who offer assistance including running customer samples. We welcome ideas and projects in developing new applications using the high resolution power of Capillary Electrophoresis.
Website: http://www.analis.com/ and http://ceofix.analis.be
Asahi Kasei Pharma Corporation
We are growing as a specialty pharmaceutical firm with a global presence by focusing on the development of new world-class drugs in selected therapeutic fields. In diagnostics, management resources are concentrated on products with strong growth prospects. The Diagnostics Department develops and manufactures enzymes for clinical chemistry use, reagents, diagnostic kits, and human enzyme calibrator for standardization, employing state-of-the-art biotechnology, for marketing to reagent manufacturers, OEM reagent manufacturers, and hospital and commercial laboratories. Our focus is on value-added, continuous innovation and quality improvement of enzymes and enzyme-related products to meet the increasing demands for greater measurement accuracy and product-handling flexibility in the clinical chemistry marketplace.
Axis-Shield Point of Care Division AS
Axis-Shield is an innovative Anglo-Norwegian company focused on the development and manufacture of important in vitro diagnostic (IVD) tests for use in clinical laboratories and at the point of care. The Group comprises a Point-of-Care Division in Oslo, a Laboratory Division in Dundee and local distribution subsidiaries in the UK (Axis-Shield UK), in Norway, Sweden, Denmark and Finland (Medinor), in Switzerland (Axis-Shield AG) and in Germany (Axis-Shield GmbH) and most of these companies also sell third-party products and non-IVD medical devices. We also have a representative office in China and a growing organisation in the USA which is primarily charged with accelerating the Afinion placement programme.
At the point of care, our products include the NycoCard range and the Afinion. In the laboratory sector we specialise in proprietary markers for the early diagnosis and management of critical illnesses such as cardiovascular and neurodegenerative diseases, rheumatoid arthritis and diabetes. We are playing an increasingly leading role in the fight against the global diabetes epidemic, and the need to keep tight control over blood glucose levels to avoid serious clinical sequelae.
BD Life Sciences – Preanalytical Systems
BD is a leading medical technology company that partners with customers and stakeholders to address many of the world's most pressing and evolving health needs. Our innovative solutions are focused on improving drug delivery, enhancing the diagnosis of infectious diseases and cancers, supporting the management of diabetes and advancing cellular research. We are more than 30,000 associates in 50 countries who strive to fulfill our purpose of "Helping all people live healthy lives" by advancing the quality, accessibility, safety and affordability of healthcare around the world. For more information, please visit: http://www.bd.com/
Beckman Coulter, Inc.
Improving Patient Health and Reducing the Cost of Care
Beckman Coulter is an organization with one of the most comprehensive product portfolios in both life sciences and clinical diagnostics. When laboratories choose Beckman Coulter as their partner, they receive distinct advantages: a legacy of quality, superior brand equity, and a highly capable team of professionals with a single focus - making laboratories more efficient and productive. We are able to design, develop, manufacture, sell and support testing systems that simplify and automate complex biomedical testing.
Our customers include hospitals, physicians' offices, diagnostic reference laboratories, pharmaceutical and biotechnology companies, universities, medical schools and research institutions. In fact, Beckman Coulter has placed more than 200,000 clinical and research instrument systems in laboratories around the world.Our diagnostic systems are found in hospitals and other critical care settings around the world and produce information used by physicians to diagnose disease, make treatment decisions and monitor patients.
- Instruments for life science research are used by scientists as they study the causes of disease, identify new therapies, and test new drugs.
Headquartered in Orange County, California, Beckman Coulter employs about 12,000 people worldwide, operating in more than 50 sites on six continents.
By offering laboratories the tools that increase the accuracy of test results and velocity of decision-making, Beckman Coulter is dedicated to improving patient health and reducing the cost of care.
The Binding Site Group Ltd.
Binding Site is a British-based company specialising in the research, development and production of immunodiagnostic kits and reagents. Binding Site manufactures a wide range of high quality and innovative products used in clinical laboratories world-wide. International support is provided in the UK, USA, Canada, Germany, Austria, France and Spain from Binding Site offices and a network of distributors in over 60 other countries.
The origins of the company go back to the early 1960's when antisera were produced to meet the needs of the Immunology department within the University of Birmingham Medical School. The range of antisera produced was small but novel and of a very high quality, leading to numerous requests for material from Immunology groups around the world. During the ensuing years the range of antibodies grew rapidly and in the early 1980's a commercial immunodiagnostic company, Binding Site, was founded.
Expertise in immunisation and processing techniques has enabled us to build a range of immunodiagnostic products aimed at fulfilling the needs of commercial and government funded laboratories in a range of markets - Hospitals, Reference Centres, Universities, Pharmaceuticals, Therapeutics - whatever their size or complexity.
Innovative new products and improved product performance are the benefits of our collaborations with numerous centres of excellence, coupled with a highly professional scientific and technical manufacturing staff.
Our product portfolio has grown to include the most comprehensive range of assays for Primary Immunodeficiency in the world. We have also been able to develop the Freelite assays, the first nephelometric tests for measuring free immunoglobulin kappa and lambda light chains in serum. These assays give a sensitivity, accessibility and consistency never before achievable, allowing significant improvements in laboratory and clinical practice for the detection and monitoring of B cell malignancies. Rigorous quality assurance procedures help ensure that we provide only products of the very highest standard and with technical support and educational programmes offered world-wide we are able to offer all of our customers the benefits of our technical expertise and knowledge. Website: www.bindingsite.com
Founded in 1952, Bio-Rad has its headquarter based in Hercules, California. It has remained at the centre of scientific discovery for more than 50 years by providing a broad range of innovative tools and services.
Bio-Rad employs more than 6,800 professionals worldwide within a network of more than 30 wholly owned subsidiaries serving more than 150 countries. Its two primary businesses include Clinical Diagnostics and Life Science research.
Bio-Rad serves more than 100,000 research, industry and clinical laboratories around the globe. It is world renowned within its core industry segments with customers in hospitals, universities, research institutions, microbiological and environmental inspection agencies, pharmacological and biological research and private industry laboratory.
Bio-Rad is the number one specialty diagnostics company. It holds leadership positions in quality control management, diabetes monitoring, blood virus testing and detection, blood typing and autoimmune disorders testing
C.P.M. Diagnostic Research SAS
Since 1986 we have been involved in hospital sanitation projects both in Italy and abroad promoted by the Cooperazione Italiana, the European Union and the Vatican Foreign Mission. Our teamwork attitude has gained us loyal customers in the construction industry, oil industry (Agip Recherches) and ONG, the Italian Red Cross, in the construction of hospital and medical centers, like the hospital in Quelimane in Mozambique, the hospital in Sidone Lebanon, the hospital in Thaoua and Zinder in Niger, the San Juan de Dios hospital in Colombia and pharmaceutical products, diagnostic material, medical supplies and hospital facilities to Bosnia, Sierra Leone, New Guinea, Haiti, the Ukraine, Angola, Guatemala, Tanzania and other countries as part of programs operated by the E.C.H.O and EU program.
On behalf of the United Nations and in collaboration with LIFE Rome, we built a totally solar powered mobile health-care unit wich was been to Salvador.
To K.P.O - Karachaganak Petroleum Operating - B.V. have been supplied emergency and intensive care ambulances where these vehicles were able to offer their service above where the climatic conditions and temperature are exesperated (+50°C / -38°C).
Moreover, since 15 years, C.P.M. SAS have a branch office in the Rupublic of Cuba recognized by the local government and where we are one of the most important distributor in Chemical Chemisty and Microbiology sector with a wide range of products registred near the local Health Authority.
C.P.M. SAS thanks to its efficiency in quality and manufacturing process have obtained the ISO 9001:2008 and ISO 13485:2004 certifications.
DiaSys Diagnostic Systems GmbH
DiaSys Diagnostic Systems is a leading specialist in development and manufacturing of diagnostic system solutions of high quality combined with ease of use and reduced environmental burden. Focusing on clinical chemistry and immunoturbidimetric tests, DiaSys has introduced more than 90 optimized reagents in user-friendly kits for manual or automated use. The products give reliable results in routine and special diagnostics as e.g. in diabetes, metabolic syndrome, lipid disorders, iron metabolism, pancreatic, kidney or liver diseases. The analytical instrumentation portfolio comprises automated clinical chemistry system analyzers for small to mid-size labs (respons®, BioMajesty®JCA-BM 6010/C), semi-automated analyzers, POCT instruments (InnovaStar®) as well as glucose/lactate analyzers (SensoStar®). Additionally, DiaSys offers a broad range of quality control material (TruLab®). DiaSys is an ISO certified company since 1996 (ISO 13485:2003, ISO 9001:2000). To date, customers and partners in more than 100 countries around the world rely on DiaSys quality.
Diatron specializes in the development, manufacturing and marketing of hematology analyzers, reagents (both for our own and other manufacturers' analyzers) and hematology control material as well as clinical chemistry analyzers, clinical chemistry reagents and controls for human medical and veterinary use. The brand name of Diatron has been established throughout the world as a result of our capability for manufacturing high quality and extremely reliable instruments, which has resulted in our products being sold and marketed in more than 100 countries. Today, there are more than 30,000 Diatron clinical chemistry and hematology analyzers in laboratory use, and our customer base continues to grow strongly year after year. All of our products have CE marking with some having FDA clearance, thus allowing sale to the USA market.
ELGA is an integral part of Veolia Water Solutions and Technologies, the world leader in water treatment. Veolia Water Solutions and Technologies has a global revenue of 2.5 billion Euros and worldwide team of 9,500 employees. It is renowned for its capabilities in providing water solutions of any size to customers throughout the entire water cycle.
Our commitment to developing and providing purified laboratory water means that you can focus on obtaining accurate results. We specialise in the following markets:
- Research and Testing
- Clinical Diagnostics
All systems are manufacture in the UK and we are accredited to ISO9001 and ISO14001 standards. We have our own R&D facilities and are always looking to provide products dedicated to providing the right water quality for your application.
ELGA focuses exclusively on water and its treatment. We continually contribute to the unique technical and scientific applications expertise developed during the last 50 years. ELGA is experienced in meeting the challenges that arise during the development, installation and servicing of single point-of-use purification systems as well as large projects involving consultation with architects, consultants and clients.
Fujirebio is a leading international healthcare company with a strong focus on high qualityin vitrodiagnostics testing solutions. Founded over 60 years ago, the company is recognized as the world-wide leader in oncology for both routine and novel markers and has a strong reputation in Japan within infectious disease testing in hospitals, clinic labs and blood banks. Over the last 20 years Fujirebio has been successfully marketing automated immunoassay testing solutions and has, under the name Innogenetics (now Fujerebio Europe), pioneered the field of molecular diagnostics and multiparameter testing. It is today among the world-leaders in strip-based diagnostics solutions.
Gentian develop, manufacture and market IVD products based on proprietary technology for flexible, high speed, high sensitivity testing.
The Gentian Cystatin C Immunoassay provides standardised and precise measurement of kidney function, which has allowed Gentian to become a leading force in introducing this novel renal marker in routine diagnostics in clinical laboratories worldwide.
Gentian's product development focuses on enhancing the assay signal strength of current particle enhanced turbidimetric and nephelometric methods for more sensitive, precise results. Following the success of this technology in the Cystatin C Immunoassay, it is now being utilized in the areas of cardiovascular, cancer, inflammation and veterinary diagnostics.Gentian is located in Oslo, Norway and Beijing, China. Valid certificates include ISO 13485:2012 and ISO 9001:2008.
Guangzhou Wondfo Biotech Co. Ltd.
Guangzhou Wondfo Biotech Co. Ltd. was founded in 1992 as a research based company in the campus of South China University in Guangzhou, Guangdong Province, China. In 2010, Wondfo moved to a new site which locates at Scientific City, Luogang Distrcit, Guangzhou. The Operation quickly grew beyond research purpose towards manufacturing of quality medical products and biochemical reagents, in particular the point-of-care testing kits and devices. Wondfo has obtained ISO 13485:2003 certificate. Its products have been cleared by the US FDA, Chinese FDA and received CE Mark.
Helena Biosciences Europe
Helena Biosciences is a leading medical diagnostic company with an international reputation comprising two flagship business divisions that specialise in the design, manufacture and support of Clinical Electrophoresis and Haemostasis systems and tests. For over three decades, the company has been a market leader in clinical electrophoresis technology, pioneering advances in the design of instrumentation, applications and software for acetate, agarose and since 2009, fully automated Clinical Capillary Electrophoresis.
HyTest Ltd., founded in 1994, offers innovative solutions for assay development and research applications by providing high-quality immunological reagents in such areas as cardiac markers, infectious, neuroscience, biological warfare agents and autoimmune disease reagents. HyTest is a leading provider of several reagents such as antibodies and antigens of the troponin I, troponin complex and Influenza A and B. HyTest offers also extensive customer services and has a certified ISO 9001:2000 quality system.
Instrumentation Laboratory (www.ilus.com), founded in 1959, is a worldwide developer, manufacturer and distributor of in vitro diagnostic instruments, related reagents and controls for use primarily in hospitals and independent clinical laboratories. The company's product lines include Critical Care systems, Hemostasis systems and Information Management systems. IL's GEM® product offerings, part of the Critical Care line, include the GEM Premier™ 4000 analyzer with Intelligent Quality Management (iQM®), GEM Premier 3500, GEMweb® Plus Custom Connectivity, and complimentary products GEM PCL Plus, a portable coagulation analyzer the ACL TOP® Family of Hemostasis Testing Systems, fully automated, high-productivity analyzers, including the ACL TOP 700, ACL TOP 700 LAS, ACL TOP 700 CTS, ACL TOP 500 CTS and ACL TOP 300 CTS. IL also offers the ACL AcuStar®, ACL ELITE®, other Hemostasis analyzers and the HemosIL® line of reagents. IL is based in Bedford, Massachusetts.
A. Menarini Diagnostics
Born as a division of pharmaceutical A. Menarini Industrie Farmaceutiche Riunite, headquartered in Florence and with over 17.000 employees in 70 countries, A. Menarini Diagnostics is a healthcare company with more than 30 years of experience in developing and leading the European market of prevention and diagnostics.
For the European healthcare community we are a dynamic and reliable partner providing innovative diagnostic solutions thanks to our deep relation with the market, and therefore, knowledge of its needs. All therapy decisions are based on reliable informed diagnosis as well as quality of life is related to prevention. These are the main reasons for our daily committed work. By focusing on well-defined and selected diagnostic areas, we create value for the society as a whole. Extensive investments in research, strategic alliances, and a constant, close, and intelligent presence into the healthcare community, allow us to be a leading European company and a trustful partner for both patients and professionals. Our aim is to make diagnostics management easier, more effective and result cost efficient.
All over Europe each client can be supported by one of our more than 700 skilled scientific consultants. In fact we are one of the diagnostics company with the most capillary presence in Europe, with our 14 fully owned subsidiaries, covering with our own network 90.3% of the population and serving a market of 300 millions people. We have a leading position in the Diabetes monitoring and our activities also cover Urinalysis, Autoimmune diseases, Hematology, Immunology, Immunohistochemistry, Wet and Dry Chemistry systems.
Mindray was founded in 1991 with the goal of delivering high-quality, competitively priced medical devices to make healthcare more accessible and affordable around the world. In 2006, Mindray listed on the New York Stock Exchange.
The company has three well-established business segments: Patient Monitoring and Life Support Products, In-Vitro Diagnostic Products and Medical Imaging Systems. Health care facilities equipped with Mindray's products can be found in over 190 countries and regions. The IVD Mindray has a global R&D network with research centers in Shenzhen, Beijing, Nanjing, Seattle, New Jersey and Stockholm. Approximately 10% of total revenue has been consistently re-invested into R&D each year. An average of eight new products has annually been introduced to the market over the past seven years. The detail information please visit our web site: www.mindray.com
Mitsubishi Chemical Europe GmbH
Mitsubishi Chemical Medience is a subsidiary of Mitsubishi Chemical Corporation. For more than 40 years now, it provides biological and medical/clinical labs with fast and highly precise analysis methods from its extensive and continuously expanded test portfolio. The outstanding quality of its appliances, reagents and service are the basis and the future perspective of the Japanese cooperation with its decades-long success story. Already back in 1982, Mitsubishi Chemical Corporation was the first company worldwide to develop the LPIA (latex photometric immunoassay) method to market maturity. Latest innovative product is PATHFAST® a fully automated chemiluminescence immuno anaylser platform for the determination of biomarkers for fast differential diagnosis in central labs and at the point of care. The Mitsubishi Chemical Medience Group is aiming for further development under the management vision of "Good Health Creator, MEDIcal+sciENCE: Creating a Healthy and Safe Society through Medical Science." Its core business today comprises the development, production and distribution of analysis devices and reagents sets based on the patented LPIA technology on the one hand, and a significant engagement in the "theranostics" sector on the other. In this sector, the company maintains global connections and cooperations with research companies and internationally operating university factories and labs today. Its major focus on research will also guarantee products with the highest possible state of development in the future. Mitsubishi Chemical Europe GmbH is the representative of diagnostic business in EMEA.
Ningbo MedicalSystem Biotechnology Co., Ltd.
Ningbo MedicalSystem Biotechnology Co., Ltd., as a leading company in the field of clinical chemistry in China, specializes in the development, manufacturing and marketing of diagnostic system solutions. MedicalSystem is certified by Quality Management System ISO 9001: 2008 and ISO 13485: 2012.
MedicalSystem focus on providing IVD products and the third party clinical diagnosis services to hospitals and other medical institutions.
MedicalSystem is committed to build the business model of "taking the diagnostic products as the core, integrating diagnostic product and service" to fulfill the needs of customers. MedicalSystem has a first-grade R&D team and obtained more than 128 in-vitro diagnostic reagents registration certificates licensed by CFDA covering most of the clinical chemistry test and becomes one of the manufacturers which offer the largest range of chemistries in China. Additionally, MedicalSystem has 4 automatic biochemistry analyzers registration certificates. The analyzers could meet customers' requirements completely. MedicalSystem is one of the largest manufacturers in Chinese IVD industry who could provide diagnostic reagents and instruments together.
MedicalSystem has established a high-level reference laboratory for standardization of their IVD products since 2009, the quality of measurement services was assured through compliance with ISO 15195: 2003 and ISO 17025: 2005 and through regular participation in appropriate EQAS. In RELA 2014, the reference laboratory (Labcode 087) has participated 19 measurands (including Enzymes, Proteins, Electrolytes, etc.) with satisfactory results. In order to improve the accuracy of patient results in clinical laboratories, MedicalSystem has developed the first EQA scheme (MSEQA) launched by Chinese IVD manufacturer which provides a means of assessing the analytical performance of a laboratory compared to others.
Nova Biomedical Corporation
Nova Biomedical's clinical laboratory business comprises point of care ivd test systems used in hospital and primary care settings. These include innovative new hand held point of care sensors as well as an array of blood gas and critical care analysers offering a wide menu range.
Oneworld Accuracy Collaboration
We invite leading clinical and research groups around the world to become Science Architects in the Oneworld Accuracy Collaboration. We embed their science in programs that assess, improve and standardize test results. We add those programs to OASYS - Oneworld Accuracy System. OASYS is an online system that can connect anyone in the world that has Internet access. We invite national groups to own the challenge of achieving testing accuracy in their countries. We empower them as Collaboration Members. We give them the tools they need: programs, online system, training and the collective experience of their Collaboration peers. We invite laboratories, doctors, clinics and pharmacies to participate in our EQA and Standardization programs. Oneworld Accuracy currently has 30 Collaboration Members who provide 25,000 program subscriptions every year to 5,000 participants in 55 countries.
Ortho-Clinical Diagnostics, Inc.
Ortho-Clinical Diagnostics For nearly 70 years, Ortho Clinical Diagnostics has provided the global healthcare community with the means to make better informed decisions. We've pioneered some of the most important, life-impacting advances in diagnostics - from our earliest work in blood typing to the latest developments in laboratory systems. Today, we serve the clinical laboratory and transfusion medicine communities worldwide. We're a leading provider of laboratory solutions as an aid in the diagnosis and treatment of disease. For more information please visit:
Royal Philips is focused on improving people's lives through meaningful innovation in health and well-being. As a global leader in providing solutions for health care, the needs of the patient are central to everything we do. By pioneering new solutions that improve and expand care around the world, we are dedicated to creating the ideal experience for all patients, young and old. Handheld Diagnostics is a dedicated business that focuses on developing innovative In-Vitro Diagnostics solutions to revolutionize Point-of-Care testing.
PPD is a leading global contract research organization providing drug discover, development and lifecycle management services. Our clients and partners include pharmaceutical, biotechnology, medical device, academic and government organizations. PPD laboratories including the Central Clinical Laboratories (US, Belgium, Singapore and China), Bioanalytical laboratories (VA. and WI) and Phase 1 Unit Clinical Laboratory (TX) provide a wide array of clinical laboratory testing services for clinical trial patients and bioanalytical assay development and specimen analysis in support pharmaceutical drug research and development.
Radiometer Medical ApS
Radiometer is a leading provider of technologically advanced acute care solutions that simplify and automate all phases of acute care testing. Radiometer's solutions cover blood sampling, blood gas analysis, transcutaneous monitoring, immunoassay testing and related IT management systems and help healthcare professionals get fast and accurate information on the most critical parameters in acute care testing. This is the foundation for making immediate and well-informed decisions on the treatment of critically ill patients in clinical settings such as emergency care, intensive care, anesthesiology, cardiac surgery, neonatal intensive care and wound care. Founded in 1935 and headquartered in Copenhagen, Denmark, Radiometer was a pioneer in blood gas testing, introducing the world's first commercially available blood gas analyzer in 1954. Today, Radiometer's products and solutions are used in hospitals, clinics and laboratories in over 130 countries, to provide information on the most critical parameters in acute care testing. In fact, five samples are performed every second on a Radiometer analyzer somewhere in the world. That's 300 samples a minute, 18,000 samples an hour, 432,000 samples a day. That's 157,680,000 samples every year performed on a Radiometer analyzer somewhere in the world.
For more information about blood gas analyzers, immunoassay analyzers, transcutaneous monitoring solutions or IT management systems, visit www.radiometer.com. For information about the latest trends in acute care testing, visit www.acutecaretesting.org, Radiometer's knowledge site.
Randox Laboratories Ltd.
Randox Laboratories, a market leader within the in vitro diagnostics industry, has 30 years experience in developing and manufacturing high quality products for laboratories worldwide. Our extensive product portfolio offers complete solutions within the fields of clinical chemistry, forensic toxicology, veterinary, drug residues, life sciences, oncology, molecular diagnostics and internal and external quality control.
Our innovative approach to diagnostics has enabled the development of a wide range of products including our benchtop clinical chemistry analysers, the RX daytona, RX imola and RX monza. The advanced functionality of each analyser ensures outstanding flexibility, optimum reliability coupled with a comprehensive test panel and cost saving features. The most recent addition to the RX series, the RX suzuka, offers high quality testing for the larger throughput laboratory.
Randox has also developed a full range of immunoassay analyser systems. The Evidence family of analysers include the Evidence, Evidence Investigator, Evidence MultiStat and Evidence Evolution. Each system incorporates revolutionary Biochip Array Technology that allows simultaneous detection of multiple analytes from a single patient sample. Rapid effortless testing, advanced consolidation and high quality results are a few of the many benefits of the Evidence analysers. The extensive biochip test menu includes both protein and DNA biochips, expanding the range to over 215 different biomarkers.
Our goal is to 'revolutionise healthcare through continuously improving diagnostic solutions'. We continue to achieve this year after year due to our commitment and significant re-investment in Research and Development. Our large support network of staff allows us to develop and perfect revolutionary products, specifically designed to provide more efficient, higher quality and reliable results, ensuring patients receive the right diagnosis at the right time.
Response Biomedical Corporation
Response Biomedical develops, manufactures and markets rapid on-site diagnostic tests for use with clinical, biodefense, and environmental applications utilizing its RAMP® platform. RAMP® represents a new paradigm in diagnostics that provides high sensitivity and reliable information in minutes. It is ideally suited to both point-of-care testing and laboratory use. The RAMP® platform consists of an instrument and single-use, disposable test cartridges; and has the potential to be adapted to more than 250 medical and non-medical tests currently performed in laboratories. RAMP® clinical tests are commercially available for the detection of RSV and Influenza A/B antigens, heart attack/ heart failure biomarkers, and fibrin degradation products characteristic of pulmonary embolism. For more details please visit the website: http://www.responsebio.com/
For more details please visit the website: http://www.responsebio.com/
Roche Diagnostics GmbH
Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics. Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and neuroscience. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management. Roche's personalised healthcare strategy aims at providing medicines and diagnostics that enable tangible improvements in the health, quality of life and survival of patients. Founded in 1896, Roche has been making important contributions to global health for more than a century. Twenty-four medicines developed by Roche are included in the World Health Organisation Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and chemotherapy.
In 2013 the Roche Group employed over 85,000 people worldwide, invested 8.7 billion Swiss francs in R&D and posted sales of 46.8 billion Swiss francs. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information: www.roche.com.
Develops, manufactures and commercializes protein electrophoresis tests and analyzers, dedicated to the in vitro diagnosis of cancer, inflammatory, metabolism and hemoglobin disorders. SEBIA's focus on electrophoresis techniques, allows a sustained R&D program, providing to any type of labs access to genuine evolution. Both agarose gel and capillary assays and their dedicated automation are designed to be integrated into the same routine workflow, for gel (ASSIST, HYDRASYS™ 2) and for capillary electrophoresis, (CAPILLARYS™ 2, MINICAP™). SEBIA has recently diversified its activity by introducing Capillarys 2 Flex Piercing, the most advanced capillary technology, providing high level of performance, bringing complete walk-away automation. Tests available are serum proteins, urine proteins, Immunotyping, high resolution electrophoresis, CDT, and haemoglobinopathy screening from whole blood in primary capped tubes. Recently, SEBIA has diversified its activity in the field of diabetes, to fulfill the growing worldwide demand for more accurate and reproducible methods for HbA1C measurement.
Sekisui Diagnostics (UK) Ltd.
YOUR GLOBAL PARTNER FOR OVER 30 YEARS
Sekisui Diagnostics was created in 2011 when Sekisui Medical acquired Genzyme Diagnostics. The new company brings together extensive product development capabilities and a broad global sales/distribution network for our comprehensive product lines:
- Clinical chemistry systems and reagents
- Coagulation systems and reagents
- Infectious disease rapid tests, line immunoassays, and ELISA Kits
- Enzymes and specialty biochemical
Sekisui Diagnostics is a diverse company with extensive product development capabilities, state of the art manufacturing facilities, and deep diagnostics expertise. We are dedicated to improving the lives of patients all around the world.
Sentinel CH. SpA
Sentinel CH SpA is an Italian company founded in 1983.
For over twenty years Sentinel has been committed to the development of innovative IVD devices in the bid to make clinical diagnosis ever more reliable.
In 2006 Sentinel moved to new high-tech premises covering a total area of about 10.000m².
The company is ISO 9001:2000, ISO 13485:2003 and ISO 13485:2003 CMDCAS certified.
Sentinel is compliant with the European Directives (98/79/CE), 21C CFR 820 "Code of Federal Regulations" FDA (U.A. Food and Drug Administration), SOE-98-282 (Canadian Medical Devices Regulations) as well as with directives of other countries, including Canada (CMDCAS). The facility, equipments and Quality System are regularly audited by Certification Body, Registrar Body and by customers and inspected by the National Competent Authority and FDA.
Sentinel's commitment to comply with IVD regulations has facilitated and supported successful partnerships in the industry as well as the distribution of Sentinel's products in over 70 countries worldwide.
Sentinel has an active presence at the major international congresses, presenting posters written by its specialised scientists. Sentinel is an active partner of IRMM projects for the release of new References Preparations for proteins.
The Technical and Manufacturing departments count for 70% of the company.
More than 100 different assays, under our own brand and also as customized kits, are manufactured in contamination-free clean rooms (ISO 8 and ISO 7 qualified).
The company's main areas of activity are:
- Clinical Chemistry
- Calibrators, controls
- Fully automated systems for Clinical and Immunochemistry, Fecal Occult Blood (FOB) testing and Coagulation.
The new Molecular Biology department initiated in 2008 has its own Production clean rooms (ISO 7) as well as R&D laboratory.
Sentinel Diagnostics: "Watching over Life"
Shanghai Kehua Bio-Engineering Co., Ltd.
Shanghai Kehua Bio-Engineering Co., Ltd. (KHB) was founded in 1981, focusing on the IVD business. In July 2004, KHB listed on the Shen Zhen Stock Exchange and is now one of the largest developers, manufacturers and marketers of in vitro diagnostic products in China, offering products mainly in two primary business segments: Diagnostic Reagents and Diagnostic Laboratory Instruments.
Based on the innovation center and post-doctoral workstation with excellent R&D professionals and talents, we have built a world class R&D platform.
We have successfully broadened our market reach by introducing more advanced products and new product lines that address different end-user segments. To date, KHB was obtained registration certificates (SFDA) for 180-plus products and 67 have been CE-marked.
Shanghai Zhicheng Biological Technology Co., Ltd
Shanghai Zhicheng is an innovative Chinese company devoted to manufacturing and marketing in vitro diagnostic (IVD) tests for use in clinical laboratories. We have been focusing on promoting the quality of our products by serious and pragmatic R&D, strict QC according to ISO 13485 and ISO 9001 since the company was founded by Mr. Wanghui in 1995. Now our products were distributed more than 1000 laboratories in China with famous brand of DENUO.
Sichuan Maccura Biotechnology Co., Ltd.
Maccura Biotechnology Co., Ltd. was incorporated in 1994. Maccura is a hi-tech enterprise certified by relevant departments. Maccura has past the CMD ISO13485, CQC ISO14001, TUV ISO13485 as well as CE Certification of some products, and obtained the CNAS Medical Reference Laboratory Accreditation. Maccura is an In-Vitro Diagnostic integration company of research & development, production, sales and services. We become the first enterprise member at IFCC. As an IVD company, Maccura is the first batch to build the enzymatic reference laboratory, and traceable results of maccura’s diagnostic products have reached the international advanced level. Maccura has been transformed into one of the leading IVD companies in China. Today, Maccura continues to grow with innovation and provide top quality IVD products and services to the world.
Siemens Healthcare Diagnostics
Siemens Healthcare Diagnostics provides healthcare professionals in hospital, reference, and physician office laboratories, and point-of-care settings with the vital information required to accurately diagnose, treat, and monitor patients. The company's innovative portfolio of performance-driven solutions and personalized customer care combine to streamline workflow, enhance operational efficiency, and support improved patient outcomes.
The company serves 30,000 customers in more than 120 countries and offers solutions for immunoassay, chemistry, automation, hemostasis, hematology, blood gas, diabetes, urinalysis, microbiology, and molecular testing, and also offers a comprehensive diagnostics IT portfolio. As a global leader in clinical diagnostics, Siemens' forward-thinking products and services are helping clinicians deliver better care so people around the world can lead healthier lives.
To learn more about Siemens Healthcare Diagnostics, please visit our Web site at www.siemens.com/diagnostics
Snibe Co., Ltd. (Shenzhen New Industries Biomedical Engineering)
As a leading company in in-vitro diagnostic in China, SNIBE focused on the research & development on immunology solution since 1995. With this strategy, SNIBE dedicated to develop, manufacture and provide an extensive range of automated immunoassay solution to hospitals, medical centers, clinical laboratories etc.
The successful launch of automated chemiluminescence immunoassay (CLIA) system, MAGLUMI series, is a great milestone of SNIBE's product development. Based on flash chemiluminescence and magnetic microbead separation technology, MAGLUMI system provides a comprehensive test menu and variety analyzers as a complete solution for laboratories' immunoassay demands. Biolumi 8000 is a powerful and flexible integrated system, including sample processing module, ISE, biochemistry and immunoassay. Continues innovation allow SNIBE fulfill the demands of our customers for lab tests.
Find out more at: www.snibe.com
Sonic Healthcare Europe
Sonic Healthcare is an international healthcare group focused on delivering quality, independent services in medical diagnostics worldwide. In eight countries across three continents, the company is structured as a decentralized federation of medically-led practices. Sonic Healthcare operates in three key segments: pathology which includes pathology/clinical laboratory services provided in Australia, New Zealand, the United Kingdom, the United States of America, Germany, Switzerland, Belgium and Ireland; radiology, which include radiology and diagnostic imaging services provided in Australia and New Zealand, and other, which includes the corporate office function, medical centre operations (IPN) and other minor operations. Sonic Healthcare employs approximately 26,000 people with its head office located in Sydney, Australia.
Sysmex Europe GmbH
SYSMEX EUROPE GMBH, Germany-based daughter company of SYSMEX CORPORATION, Kobe, Japan, is responsible for customer and sales support for Sysmex's in vitro diagnostic systems and reagents as well as manufacture and sales of reagents for Sysmex's in vitro diagnostic systems in the European, African and Middle East markets.
Sysmex, a manufacturer of comprehensive clinical testing, is engaged in clinical laboratory testing of blood, urine and other specimens, covering the areas of haematology, haemostasis, immunochemistry, biochemistry, urinalysis and faecal occult blood testing.
In the field of haematology, Sysmex holds the global market leader position. In addition to providing instruments and reagents for clinical laboratory testing, Sysmex is also developing a broad range of laboratory information systems and application software, thus offering information technology as part of its comprehensive service and support system. Integration of those various technologies is the driving force behind Sysmex's business activities.
Sysmex is also developing these technologies and expertise to expand its areas of business. For example, it is expanding into such fields as point of care (POC) testing - clinical laboratory tests conducted on the spot, such as in the hospital operating room, intensive care unit, or at the clinic - to enable faster diagnoses, centralized test data management for improved testing efficiency, and the establishment of local healthcare networks to link hospitals and clinics.
At the same time, Sysmex is also creating new core technologies to address the challenges of disease prevention and early cancer detection.
By expanding its business into these healthcare testing fields, Sysmex intends to contribute to the creation of a vibrant and healthy society. In addition, Sysmex is applying the technologies that it has devised in the field of clinical laboratory testing to industry, sports, and other new business fields.
At Sysmex, we have adopted two commitments to the future: to continually develop advanced technologies and create value with the aim of serving our customers and society at large; and to play a key role in contributing to the health and vitality of people the world over. It begins with close attention to the voices of our customers.
Thermo Fisher Scientific
Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with revenues of $17 billion and 50,000 employees in 50 countries. Our mission is to enable our customers to make the world healthier, cleaner and safer. We help our customers accelerate life sciences research, solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Our four premier brands - Life Technologies, Thermo Scientific, Fisher Scientific and Unity Lab Services - offer an unmatched combination of innovative technologies, purchasing convenience and comprehensive support. For more information, please visit: http://www.thermofisher.com/
Unilabs, Laboratoire d'analyses médicales SA
Unilabs is a leading clinical European supplier of laboratory medicine and radiology services with operations in 12 European countries.
Unilabs supplies diagnostics services to:
- Public and Private healthcare units
- Outpatient clinics
- Occupational health units
- County councils
- The general public
- Insurance companies
Unilabs also provides Laboratory and Logistics services for drug development companies & CROs.
Wako Pure Chemical Industries, Ltd./Wako
Wako Pure Chemical Industries, Ltd. was established in 1922 as a predecessor of Takeda Chobei Shoten (currently, Takeda Pharmaceutical Company Limited) pharmaceutical department.
Interest in healthcare continues to grow. High hopes are now pinned on the diagnostic tests to enable prevention of diseases, as well as their early detection and treatment.
Wako Pure Chemical Industries, Ltd. is engaged in the research, development, and manufacturing of a diverse range of products, such as assay kits for the diagnosis of cancer and life-style related diseases, and infectious disease assays.
We are also steadfastly fulfilling our mission as a comprehensive diagnostic reagent manufacturer by developing assays that integrate reagents and instruments, and by promoting comprehensive total solutions for medical management and operations.
We will contribute to the advancement of the quality of medicine by continuing to develop valuable assays in cutting-edge areas, supporting future medicine such as disease prognosis and diagnosis, and predisposition detection.
Labor Dr. Wisplinghoff
Wisplinghoff diagnostic services are backed by a strong team of 29 medical doctors and scientists in Cologne.
contribute to the overall progress of healthcare by leading collaborations with industry and academic institutions in order to develop new techniques, carry out research and promote synergies between our scientists, academics and colleagues in the industry.