Diagnostic Device Manufacturers

American Diagnostic Corporation (ADC) manufactures diagnostic instruments for healthcare professionals and institutions. The company designs, assembles, tests, and packages products like blood pressure cuffs and gauges, with over 50% of manufacturing operations in New York. ADC focuses on exceptional quality and performance.

AggreDyne, Inc. is a Houston, TX-based medical diagnostic company developing FDA-cleared and CE marked in-vitro diagnostic products. They specialize in best-in-class, on-demand platelet function testing tools, such as the AggreGuide A-100, for hospital, physician office, and regional reference laboratories.

Based in Houston, TX, AJ Medical Manufacturing is an ISO 13485 and FDA registered contract manufacturer of medical devices and components. They offer vertically integrated manufacturing services and medical device design. Their agile approach aims to shorten time to market and reduce inventory costs for customer partners.

Alliance Tech Medical, Inc. specializes in manufacturing diagnostic devices for respiratory disease management. The company produces individually calibrated peak flow meters, FEV1 monitors, and pulmonary function testing filters. They also offer inhaler technique training and assessment tools for both children and adults.

Alveo Technologies develops molecular detection platforms and diagnostic devices for rapid, on-site pathogen detection. Their Alveo Sense™ system delivers quick, traceable results for animal health, including avian influenza testing for poultry and livestock, alongside applications in human and public health.

Argon Medical Devices manufactures innovative medical products, including diagnostic devices, tailored for interventionalists and specialists. The company focuses on developing advanced solutions to enhance procedural efficacy for healthcare professionals and improve patient outcomes through their specialized device development.

Based in Fremont, CA, ARK Diagnostics, Inc. designs, develops, and manufactures in vitro diagnostic immunoassays. They specialize in therapeutic drug monitoring and urine drug testing, offering high-quality, liquid, stable, and ready-to-use assays for clinical chemistry systems.

Based in Plano, TX, Aspen Imaging manufactures and distributes next-generation medical imaging devices. They specialize in X-Ray Systems, Mobile X-Rays, C-Arms, and Flat Panel Detectors. The company offers patented X-ray technology, like the Europa series, featuring built-in screens for instant viewing and rapid diagnosis.

Attogene Corporation manufactures universal lateral flow products and materials, including assays utilizing quantum dots, gold, and europium. They also provide rapid diagnostic kits for heavy metals and cyanotoxins, leveraging ELISA, PCR, and lateral flow immunoassay technologies. Attogene further offers specialized lateral flow development services.

BD (Becton, Dickinson and Company) is a medical technology company advancing global healthcare through innovative solutions. Specializing in diagnostic device manufacturing, BD develops comprehensive diagnostic solutions, including rapid patient-side tests and the BD COR™ system, for improved patient outcomes.

Based in Houston, TX, Biotex Inc. is an ISO-certified, FDA-registered medical device CDMO. With over 25 years of experience, they specialize in the design, development, and manufacturing of life-changing medical devices, transforming ideas into groundbreaking solutions for patient care and commercialization.

Based in El Cajon, CA, Calbiotech is an FDA-registered, ISO 13485-certified CDMO. They provide comprehensive services for in vitro diagnostics (IVDs), including custom assay development, scalable contract manufacturing, reagent formulation, and filling. Calbiotech supports clients from concept to commercialization and U.S. market access.

Based in Milford, NH, Cirtronics is a contract manufacturer specializing in complex electronic and mechanical systems. They provide full-service manufacturing solutions for medical devices, including Class II devices, imaging systems, and surgical equipment, from engineering to fulfillment.

Based in South San Francisco, CA, Cytovale Inc. develops and manufactures the IntelliSep medical device. This FDA-cleared in vitro diagnostic test provides rapid sepsis risk stratification, delivering results in approximately 8 minutes to optimize patient outcomes.

Based in Fort Worth, TX, DesignPlex Biomedical LLC provides full-spectrum prototyping, design development, and contract manufacturing for FDA Class II and III medical devices. They specialize in crafting complex cardiovascular and neuromodulation devices, offering robust engineering and end-to-end GMP manufacturing services.

Based in Poway, CA, Diazyme Laboratories Inc. specializes in the research, development, manufacture, and distribution of high-quality diagnostic reagents. The company leverages proprietary enzyme and immunoassay technologies to create accurate products for automated analyzers, supporting healthcare professionals globally.

Based in Coralville, IA, Digital Diagnostics pioneers AI-driven healthcare, developing FDA-cleared diagnostic devices. Their LumineticsCore AI solution diagnoses diabetic retinopathy at the point-of-care, increasing patient access and expediting referrals. The company transforms medical care by enhancing accessibility, affordability, and quality with AI.

Based in San Diego, CA, Epitope Diagnostics Inc. is a certified medical device manufacturer focusing on in-vitro diagnostics. The company offers niche immunoassays, including ELISA kits, rapid tests, and antibodies, leveraging CLIA chemiluminescence, automated ELISA, and rapid test platforms.

Based in Mountain Lakes, NJ, Euroimmun US manufactures innovative in vitro diagnostic (IVD) devices and kits. They specialize in a wide range of diagnostic areas, including autoimmune, allergy, antigen, infection, and molecular genetic testing. The company utilizes advanced techniques such as IFA, ELISA, Immunoblot, and real-time PCR to provide comprehensive diagnostic solutions.

Based in Euless, TX, Fine Line Production manufactures custom medical equipment and components. They specialize in creating essential support structures such as equipment stands, cabinets, enclosures, housings, laboratory tables, carts, instrument stands, and workstations for the healthcare industry.

Fluxergy Inc. provides an all-in-one benchtop lab platform for rapid, multimodal, point-of-care diagnostic testing. They specialize in molecular (PCR), immunochemistry, cytometry, and electrochemistry, manufacturing analyzers and test cards. The company offers solutions for human health, animal health, and environmental applications.

GE HealthCare provides advanced diagnostic devices and integrated solutions for hospitals and clinicians. They offer products such as imaging, ultrasound, diagnostic ECG, patient monitoring, and molecular imaging agents. The company focuses on precision care and patient-focused technologies to enhance diagnosis, treatment, and patient monitoring.

Abbott manufactures portable diagnostic analyzers and tests for diverse point-of-care applications. Offerings include CLIA-waived blood chemistry tests, whole blood tests for mild traumatic brain injury, and assays for myocardial infarction diagnosis. They also provide rapid COVID-19 and Influenza A & B detection.

HDA Technology specializes in the creation and manufacturing of medical devices for clients nationwide. The company builds a range of devices, serving various medical sectors. With its base of operations in California, HDA Technology focuses on precision and quality in medical device production.

Based in Houston, TX, Healgen is a global in-vitro diagnostics (IVD) developer and manufacturer. The company specializes in producing rapid antigen tests for conditions like COVID-19 and Flu A&B, along with multi-drug urine screening and fentanyl rapid tests.

Based in Marlborough, MA, Hologic, Inc. is a medical technology company that manufactures diagnostic devices and systems. Focused on improving women's health through early detection, they provide solutions in mammography, cervical health, molecular diagnostics, and blood screening for various healthcare needs.

Based in Seattle, WA, InBios International, Inc. manufactures immunodiagnostics for infectious diseases. They provide FDA-cleared respiratory diagnostics, including CLIA-waived point-of-care and over-the-counter tests for COVID-19 and Flu A&B. The company operates under GMP, FDA registration, and ISO 13485 certification.

Based in Austin, TX, International Biomedical Ltd. specializes in designing, manufacturing, and distributing innovative neonatal and perinatal products. The company directly produces a range of medical devices crucial for the care of newborns and expectant mothers, covering various applications within the healthcare sector.

Based in Portsmouth, NH, Laborie Medical Technologies Corp. is a medical technology company specializing in diagnostic and therapeutic solutions. They develop and provide devices for gastroenterology, urology, urogynecology, obstetrics, gynecology, and neonatal health, focusing on advanced care in these fields.

LeeMAH Electronics is a custom contract manufacturer providing end-to-end electronic assembly solutions, including PCBA, cable assembly, box build, and testing. With over 40 years of experience, the company serves OEMs with high-mix, low-medium volume needs across various sectors, notably the medical device industry from its US facilities.

Based in Santa Clara, CA, Lumiquick Diagnostics, Inc. manufactures in-vitro diagnostic devices. They offer rapid immunochromatographic assays and ELISA tests. Product lines include infectious diseases, drugs of abuse, cancer, cardiac, and fertility markers, serving healthcare and research sectors with diagnostic solutions.

Based in Irvine, CA, mdxhealth develops personalized molecular diagnostic solutions for urologic diseases, primarily prostate cancer. They offer diagnostic tests like ExoDx Prostate Test, Confirm mdx, and Genomic Prostate Score to improve earlier detection of aggressive cancer, informing patient management.

Based in Cincinnati, OH, Meridian Bioscience develops, manufactures, and distributes a range of diagnostic solutions. The company specializes in tests for gastrointestinal and upper respiratory infections, as well as blood lead level diagnostics. They provide innovative technologies to improve health outcomes for patients globally.

Merit Medical Systems, Inc. is a manufacturer of proprietary disposable medical devices. They specialize in products used in interventional, diagnostic, and therapeutic procedures for various medical fields, including cardiology, radiology, oncology, critical care, and endoscopy. Merit serves client hospitals and physicians worldwide from its facilities.

Based in Wayzata, MN, Natus Medical Incorporated manufactures diagnostic devices and solutions. The company specializes in products designed to screen, diagnose, and treat neurological disorders affecting the brain, neural pathways, and sensory nervous systems, simplifying complex care and research.

Based in Dayton, OH, Norwood Medical specializes in precision medical device manufacturing, including post-processing and assembly services. They cater to demanding markets such as cardiovascular, minimally invasive surgery, orthopedics, robotic-assisted surgery, and general surgical technologies, providing manufacturing expertise for medtech innovations.

Nuclein, LLC, based in Austin, TX, manufactures the DASH™ Rapid PCR System. This point-of-care platform delivers lab-quality, sample-to-answer PCR results in 15 minutes. They offer FDA-cleared, CLIA-waived diagnostic tests, including the DASH SARS-CoV-2 & Flu A/B Test, providing rapid and affordable solutions for healthcare.

Omega Medical Imaging, headquartered in Sanford, FL, designs and manufactures state-of-the-art AI-powered diagnostic imaging systems. Specializing in advanced medical imaging technology, the company focuses on significantly reducing radiation exposure during procedures, enhancing patient safety and diagnostic capabilities for healthcare providers nationwide.

Based in Fremont, CA, Paragon Genomics specializes in developing and manufacturing CleanPlex® kits. These custom and ready-to-use multiplex PCR solutions are designed for targeted DNA and RNA amplicon sequencing, serving advanced genomic research and diagnostic applications.

Based in San Diego, CA, QuidelOrtho manufactures advanced diagnostic devices and systems. The company transforms diagnostic data into actionable intelligence, providing vital health information across healthcare settings. Its portfolio includes VITROS™ Systems, the SOFIA™ Platform for rapid testing, and ORTHO™ Immunohematology Analyzers.

Based in Bland, MO, Roberson Machine Company provides precision CNC machining, milling, turning, wire EDM, and 3D printing services. They support medical device development from prototype to full production, alongside aerospace, automotive, and electronics industries. The company focuses on quality, reliability, and cost-effective manufacturing.

SCHILLER Americas manufactures and innovates a range of diagnostic, resuscitation, monitoring, and software equipment. With 50 years of industry experience, they provide EKGs, lung function devices, and patient monitoring systems. They serve general practice, hospitals, lung function labs, and government sectors.

Based in San Diego, CA, SEKISUI Diagnostics is a global partner specializing in the innovation and development of highly accurate diagnostic and biochemistry products. The company provides intelligent solutions and point-of-care diagnostic devices to improve patient outcomes.

Based in San Antonio, TX, Seno Medical manufactures the Imagio® Breast Imaging System. This diagnostic device leverages light, sound, and AI-powered SenoGram® for real-time functional imaging, supporting accurate assessment of breast masses as benign or malignant with a single exam.

Based in Eden Prairie, MN, Smart Diagnostic Devices manufactures durable, affordable, and reliable touch-screen audiometers. The company provides diagnostic solutions specifically designed for occupational healthcare professionals, ensuring accurate and consistent hearing assessment.

Spartronics provides FDA-registered electronic contract manufacturing services for medical devices and life sciences. They specialize in PCBAs, subsystem integration, and full-box builds for highly-regulated complex products. Additional offerings include value-added engineering, manufacturing readiness, and supply chain solutions.

Based in Eden Prairie, MN, Surmodics, Inc. provides in vitro diagnostic technologies, including chemical components for IVD immunoassay tests and microarrays. The company also offers end-to-end development and scalable manufacturing for complex medical devices and specialized coatings, serving the healthcare industry.

Based in Anaheim, CA, Teco Diagnostics manufactures private-label over-the-counter medical test kits and IVD components. Their FDA-registered, CE-marked solutions include urinalysis strips, rapid tests, clinical chemistry reagents, and women's health products, all produced and distributed globally from their US facility.

Based in Carlsbad, CA, True Diagnostics develops and manufactures innovative diagnostic tests and products. The company offers integrated assay development, reagent manufacturing, and device assembly services for government, clinical, and commercial partners. Their solutions provide lab-quality results even in challenging testing environments.

Diasorin manufactures diagnostic devices for the laboratory diagnostics market. Specializing in immunodiagnostics and molecular diagnostics, the company offers solutions like LIAISON® MeMed BV® and LIAISON® BRAHMS PCT®. These empower faster, accurate triage and reduce unnecessary antibiotic use, alongside LIAISON PLEX® assays for bloodstream infection diagnostics.

Based in Honolulu, HI, United Imaging manufactures advanced medical imaging equipment. Their product portfolio includes state-of-the-art CT scanners like uCT ATLAS, MRI systems such as uMR 680, digital high-resolution PET/CT (uMI Panorama), and mobile digital X-ray (uDR 380i Pro) for various clinical applications.

Veracyte Inc. based in South San Francisco, CA, develops and commercializes advanced genomic tests for personalized cancer care. Their diagnostic solutions, including Afirma, Decipher, Prosigna, and Percepta tests, offer clinicians a complete diagnostic picture. This enables informed treatment plans for patients, advancing precision medicine in oncology.

Based in Plano, TX, Virtex delivers precision-engineered, compliant manufacturing for Class I-III medical devices. They provide high-reliability electronic solutions, including printed circuit board assembly, cable & harness, and full-system integration. Virtex supports the medical device, aerospace, defense, space, and industrial markets.

Based in Boerne, TX, EKF Diagnostics USA (Stanbio Laboratory) manufactures diagnostic devices and reagents. They produce chemistry reagents for diabetes care, such as β-Hydroxybutyrate LiquiColor® tests. Offerings encompass analyzers for hemoglobin, hematocrit, and mothers’ milk lipid content.

Based in San Francisco, CA, HORIBA develops and manufactures in vitro diagnostic systems for healthcare, serving laboratories, clinics, and hospitals. They offer comprehensive hematology, hemostasis, and clinical chemistry solutions, including analyzers, reagents, and consumables. HORIBA also provides OEM spectroscopy and imaging components for various R&D and industrial applications in life sciences.

Illumina provides comprehensive solutions for clinical laboratories to develop and implement next-generation sequencing (NGS)-based molecular diagnostic tests. Their offerings enable the creation and deployment of advanced diagnostic devices, supporting the diagnostic industry.

Leica Biosystems provides integrated workflow solutions and automation for advancing cancer diagnostics, from biopsy to diagnosis. They manufacture advanced staining instruments, histology solutions for slide preparation, and digital pathology systems, all designed for in vitro diagnostic use.

Based in Vacaville, CA, MagniBiosens LLC develops and engineers cutting-edge biosensor solutions. Their biosensors enable real-time monitoring for life sciences, healthcare, and diagnostic applications. They also provide solutions for environmental, animal, and plant health monitoring, transforming interactions with biological systems.

Microbiologics provides biomaterials, anti-infective testing, and assay development services for microbiology, molecular diagnostics, and virology. They offer comprehensive CRO services to support diagnostic device manufacturers in the development and validation of their products and assays.

Siemens Healthineers specializes in medical technology, delivering intelligent imaging and digital tools to optimize radiology workflows and accelerate diagnosis. The company develops advanced diagnostic devices and solutions, enhancing quality and improving patient care for conditions like cancer and heart disease.

Texas BioGene Inc. (TBG) is a molecular diagnostics company based in Houston, TX, specializing in the development, manufacture, and marketing of nucleic acid testing kits. They provide a range of diagnostic solutions for infectious diseases, including COVID-19, influenza, RSV, and HPV genotyping, serving clinical and research markets.

Based in Richmond, TX, Velentium Medical is a professional engineering firm specializing in the design and manufacture of Class II and Class III medical devices. They transform intellectual property into safe and secure products, offering services in R&D, medical device manufacturing, cybersecurity, and test systems.

Based in San Diego, CA, Able Diagnostics, Inc. manufactures medical diagnostic devices. The company specializes in high-quality, competitively priced products such as Blood Glucose Monitoring Systems, No Touch Infrared Forehead Thermometers, Blood Lancets, and Pet Glucose Monitoring Systems, primarily serving the US market.

Based in Santa Clara, CA, Agilent is a global leader in life sciences, diagnostics, and applied chemical markets. The company manufactures a comprehensive portfolio of analytical instruments, software, services, and consumables. They specialize in developing and producing advanced diagnostic devices and laboratory solutions for research and clinical applications.

Alamar Biosciences is a proteomics company based in Fremont, CA, specializing in advanced protein biomarker detection. They develop high-precision technologies that redefine the limits of identifying critical protein biomarkers, essential for diagnostic device development and various clinical applications.

Based in Carlsbad, CA, Argonaut Manufacturing Services is a contract manufacturing organization. They specialize in IVD and Life Sciences product manufacturing, offering comprehensive aseptic and non-aseptic fill-finish services, lyophilization, and analytical support. Argonaut also provides drug-device combination product development and manufacturing for the diagnostic industry.

Based in Durham, NC, Avioq, Inc. is an in-vitro diagnostic medical device company. It specializes in developing, producing, and distributing quality IVD products. They offer flexible contract manufacturing and development services within an FDA licensed and ISO 13485 certified environment, supporting IVD assay development and companion diagnostics.

Based in Newbury, OH, DEM Medical provides vertically integrated product development services for medical devices. The company handles projects from concept to production, offering design, engineering, rapid prototyping, and U.S.-based manufacturing. Capabilities include custom cabling, PCB assemblies, injection molded components, and tooling design and fabrication.

Roche Diagnostics manufactures in vitro diagnostic (IVD) devices and systems. The company provides solutions for various diagnostic applications, including advanced laboratory instruments such as the LightCycler® PRO System. They showcase innovations and engage with professionals at key industry events like EuroMedLab.

Based in Grand Rapids, MI, Fortis Life Sciences offers contract development and manufacturing (CDMO) services for diagnostic and life science companies. They provide an integrated portfolio of reagents, components, and solutions, specializing in diagnostic assay CDMO, enzyme & master mix CDMO, and lyophilization services.

Freenome Holdings, Inc. is a biotech company specializing in the development of early cancer detection solutions. They combine multiomics technology and artificial intelligence with standard blood draws to create intelligent screening platforms. Their rigorous clinical programs drive the discovery, development, and validation of diagnostic tests.

GRAIL specializes in developing and providing multi-cancer early detection tests. The company leverages next-generation sequencing and population-scale clinical studies to alleviate the global burden of cancer through early diagnosis.

Guardant Health is a precision medicine company specializing in data-driven cancer diagnostics. They develop proprietary liquid biopsy tests, leveraging advanced technology to transform patient care and combat cancer. The company provides comprehensive genomic insights and monitoring solutions, with its own laboratory operations and scientific workforce based in the US.

Based in San Diego, CA, Invivoscribe, Inc. develops and manufactures precision diagnostic assays for hematology-oncology, particularly leukemias and lymphomas. The company provides standardized CE-marked in vitro diagnostic cGMP products, RUO assays, and analyte specific reagents, including CDx solutions for approved drugs.

Based in Charlotte, NC, Keller Technology specializes in custom manufacturing medical equipment and diagnostic instruments. The company provides fabrication services for various devices used in demanding healthcare and medical applications, focusing on high-quality, precision-engineered solutions for the industry.

Based in San Jose, CA, AccuraGen, Inc. specializes in developing advanced technology and innovative approaches for cancer diagnostics. The company focuses on creating diagnostic solutions for the healthcare industry.

Beckman Coulter Diagnostics provides accurate diagnostic information and devices, supporting healthcare professionals in delivering better patient care. They offer advanced solutions for laboratories, empowering critical moments in medical diagnostics.

Based in Hercules, CA, Bio-Rad develops and manufactures products for the life science research and clinical diagnostic markets. They provide systems, instruments, software, and consumables used in disease diagnosis, drug discovery, and various testing applications globally.

Cepheid manufactures molecular diagnostic testing solutions, offering robust portfolios for respiratory health and various infectious diseases. They specialize in multiplex testing, providing fast, clinically relevant results for improved patient care. Their GeneXpert system is utilized for impactful screenings, including cervical cancer and tuberculosis.

Based in Marlborough, MA, Cytiva Life Sciences provides specialized diagnostic services tailored for lab-based immunodiagnostic assay development. Their offerings encompass customization and comprehensive assay development, supporting manufacturers in accelerating the creation of vital diagnostic devices. They utilize their extensive life science expertise to serve the healthcare sector.

Based in San Diego, CA, Grifols Diagnostic Solutions Inc. is a global leader in transfusion medicine and a pioneer in disease detection. The company provides innovative diagnostic solutions and products to improve transfusion safety and clinical diagnostics for blood banks and hospital transfusion centers.

Foundation Medicine, Inc. pioneers high-quality precision diagnostic solutions for cancer and beyond. The company provides critical information on genomic alterations through advanced tests, supporting drug discovery, development, and clinical workflow efficiency with EMR integrations.

Freudenberg Medical is a contract development and manufacturing organization (CDMO) specializing in medical devices and IVD products. They offer vertically integrated services from ideation to series manufacturing, utilizing expertise in precision molding, extrusion, and advanced materials. They have global production sites, including facilities in Southern California.

Abbott Molecular provides molecular intelligence, offering assays and automation for personalized healthcare in infectious disease, oncology, and genetics. They manufacture FDA-approved self-collection devices for HPV and STI screening, alongside pre-analytical instruments. These in-vitro diagnostic solutions enhance clinical and operational efficiencies for healthcare providers.

OraSure Technologies, Inc. transforms health through actionable insights by decentralizing diagnostics. The company pioneers non-invasive testing devices and sample collection tools. It empowers individuals, healthcare providers, and researchers to improve health outcomes with its innovative solutions.

Based in Austin, TX, Texas Contract Manufacturing Group (TCMG) provides end-to-end manufacturing solutions for medical device projects. They specialize in turnkey manufacturing, fabrication, and assembly of high-complexity, precision machined metal components, supporting clients from prototyping to large-scale production.

Based in Carlsbad, CA, Thermo Fisher Scientific provides integrated diagnostic testing instruments and solutions. The company enables lab-developed assays, automates specific tests, and maximizes lab productivity. They also offer high-performance secondary and flow antibodies, essential components for diagnostic research and laboratory applications.

Abbott Toxicology, located in Santa Rosa, CA, is a division of Abbott specializing in the manufacture and provision of diagnostic devices for toxicology. They offer a range of products and laboratory services, including eScreen Services, to support government and commercial drug and alcohol screening programs.