Ivd Manufacturers

Based in San Diego, CA, ACON Laboratories, Inc. manufactures a comprehensive range of In Vitro Diagnostic (IVD) products. They specialize in Point of Care, Immunoassays, Molecular Diagnostics, and Animal Health, offering lateral flow rapid tests for infectious diseases, pregnancy, and cancer markers. The company also provides contract manufacturing services.

Based in Elkhart, IN, Agdia, Inc. develops and manufactures plant pathogen and GMO testing solutions. The company provides a comprehensive portfolio of diagnostic test kits, including ImmunoStrip® and ELISA formats, alongside custom immunoassay and molecular test development services. Agdia serves clients worldwide.

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

Based in Fremont, CA, ARK Diagnostics, Inc. designs, develops, and manufactures in vitro diagnostic immunoassays. Their solutions target therapeutic drug monitoring and urine drug testing. These assays are liquid, stable, and ready-to-use, with applications available for various clinical chemistry systems.

Based in Austin, TX, Attogene is a biomanufacturing company specializing in the development and production of in vitro diagnostic products. They offer universal lateral flow assays, serology kits, and fluorescent dipsticks. Attogene also provides various cyanotoxin test kits, including ELISA, rapid tests for water, and qPCR detection kits.

AVISE specializes in advanced autoimmune lab tests, supporting rheumatologists and patients in the diagnosis, prognosis, and management of lupus and complex autoimmune diseases. They offer comprehensive solutions, including CB-CAPS and AVISE testing, to aid healthcare providers with differential diagnosis, monitoring, and therapeutic optimization.

BD is a global medical technology company manufacturing a broad range of medical products, capabilities, and diagnostic solutions. It specializes in in vitro diagnostics, offering products for areas like cervical cancer screening, and develops connected care platforms. The company is dedicated to advancing global health initiatives.

Based in Irvine, CA, Biomerica specializes in IVD assay development and manufacturing. The company offers contract development and manufacturing services, providing comprehensive regulatory support for FDA, CE, ISO, and IVDR compliant products. They operate from registered manufacturing facilities, serving the in vitro diagnostics industry.

Biomerics is a vertically integrated contract manufacturer based in Salt Lake City, UT, specializing in medical devices. They provide end-to-end solutions from design and material engineering to finished interventional components and devices. Their expertise includes polymer and metal capabilities for complex medical applications.

Based in Houston, TX, Biotex Inc. is an ISO-certified and FDA-registered medical device CDMO with over 25 years of experience. The company offers comprehensive design, development, engineering, and manufacturing services. They partner to transform innovative ideas into groundbreaking medical device solutions for patient care.

Based in El Cajon, CA, Calbiotech specializes in IVD design, development, and contract manufacturing. They offer custom assay development, reagent formulation, and end-to-end IVD production services. As an FDA-registered and ISO 13485-certified U.S. manufacturer, Calbiotech supports diagnostic innovation from concept to commercialization for various partners.

Castle Biosciences develops and delivers advanced molecular diagnostics and prognostic tests, including genomic profiling for melanoma, skin cancers, and atopic dermatitis. The company focuses on providing personalized genomic information to healthcare providers and patients, aiming to better inform care decisions and improve patient outcomes.

Dhaliwal Labs is a contract development and manufacturing organization (CDMO) specializing in In Vitro Diagnostics (IVD) products. With state-of-the-art facilities in Texas and Illinois, they offer comprehensive services from development to manufacturing for commercial clients, supporting various stages of the IVD product lifecycle.

Based in Broomall, PA, Drummond Scientific Company develops custom manufacturing solutions and provides essential sample handling devices for life science companies. They specialize in products such as micropipettes and microinjection systems. The company is ISO 13485:2016 Certified for medical device manufacturing.

Based in Torrance, CA, DxTerity pioneers diagnostics for autoimmune diseases. The company provides personalized care powered by advanced RNA diagnostics, offering new insight into the biological underpinnings of these conditions. They develop and manufacture innovative diagnostic solutions for healthcare providers.

EKF Diagnostics develops in-vitro diagnostic (IVD) devices and tests, offering quick, accurate results for point-of-care and central lab analysis. The company supplies high-quality reagents, enzymes, and components to research, biotech, and pharma sectors. EKF empowers healthcare decision-making with its innovative medical technologies.

Based in San Diego, CA, Epitope Diagnostics Inc. is a certified medical device manufacturer specializing in niche immunoassays. The company provides a range of in-vitro diagnostic products, including ELISA kits, rapid tests, and antibodies, utilizing platforms like CLIA and automated ELISA to serve the global healthcare community.

Euroimmun US is a manufacturer of in vitro diagnostic (IVD) test systems for medical laboratories, specializing in autoimmune, infectious, molecular genetic, allergy, and antigen diagnostics. The company provides a comprehensive range of techniques including IFA, ELISA, Immunoblot, ChLIA, Microarray, Real-time PCR, Radioimmunoassays, and Westernblot/EUROLINE-WB.

Exagen Inc. provides advanced in vitro diagnostic (IVD) testing, enabling physicians to accurately diagnose, prognose, and monitor autoimmune conditions. The company operates a fully functional, certified laboratory dedicated to addressing the needs of patients with autoimmune disorders through specialized diagnostic solutions.

Fluxergy Inc. develops and manufactures an all-in-one benchtop lab for rapid, point-of-care diagnostic testing. Their multimodal platform supports molecular (PCR), immunochemistry, cytometry, and electrochemistry assays for human and animal health. They produce test cartridges and systems, enabling on-site insights for common tests.

Based in San Antonio, TX, Germaine Laboratories, Inc. is an FDA-registered manufacturing facility specializing in developing and supplying medical diagnostic tests. They produce IVD tests for COVID-19, drug abuse, influenza, and pregnancy, serving medical, drug testing, veterinary, and food & beverage industries.

Gila Bioscience, a Contract Development and Manufacturing Organization (CDMO), provides custom assay development and GMP-compliant production for point-of-care diagnostics. They deliver scalable, regulatory-ready manufacturing solutions across clinical, veterinary, environmental, pharma, and biodefense markets, guiding projects from concept to commercial launch.

Abbott Point of Care manufactures advanced in vitro diagnostic (IVD) products for rapid, point-of-care testing. They offer portable diagnostic analyzers, like the i-STAT system for CLIA-waived blood chemistry and cardiac markers. Additionally, they produce rapid molecular and antigen tests for COVID-19 and influenza.

Gold Standard Diagnostics Horsham LLC develops, manufactures, and markets rapid environmental, food, and life sciences test systems. They specialize in immunochemistry products and methods, including immunoassay and rapid test kits, to meet testing needs for research and industry. Many products are validated by agencies like US EPA, USDA, and FDA.

Based in Santa Maria, CA, Hardy Diagnostics is an ISO 13485 certified, employee-owned manufacturer. They specialize in producing microbiology media, reagents, and kits for clinical diagnostics, pharmaceutical, and food safety testing. The company also offers general lab supplies and products for proficiency testing.

Based in Foresthill, CA, HDA Technology provides end-to-end medical device engineering, prototyping, and contract manufacturing. ISO 13485 certified and FDA-registered, they ensure compliant production from concept to market. The company offers comprehensive support for various medical devices, making them relevant for IVD manufacturers.

Healgen is a global in-vitro diagnostics (IVD) developer and manufacturer based in Houston, TX. The company produces high-quality rapid diagnostic tests, including FDA 510(k) cleared COVID-19/Flu A&B antigen tests, multi-drug urine drug screen cups, and fentanyl rapid tests for healthcare and over-the-counter use.

Based in Lexington, MA, FUJIFILM Healthcare Americas Corporation manufactures a comprehensive line of in-vitro diagnostics. Their offerings include FUJIFILM Liver Biomarkers, aiding in the early detection of HCC. The company also provides advanced diagnostic, enterprise, and endoscopic imaging solutions, innovating for a healthier world.

Helena Laboratories Corporation manufactures electrophoresis analyzers, densitometers, hemostasis reagents, and immunology and protein diagnostic instruments. Their products include the SPIFE Nexus for isoenzyme analysis and Plateletworks for rapid platelet function screening, serving clinical laboratories.

Based in San Diego, CA, HiComp specializes in microfluidic device manufacturing for clinical diagnosis, diagnostics, and life sciences. The company offers design, prototyping, and high-volume cleanroom production using PDMS, injection molding, and MEMS technologies. They provide end-to-end device integration with biological readiness and maintain ISO 13485 compliance for medical devices.

Hologic provides advanced molecular diagnostic solutions and scalable testing platforms, including the Panther system, which enhances flexibility and capacity for expanding testing menus. This company is a prominent manufacturer of in vitro diagnostic products, focusing on women's health.

Immundiagnostik, Inc. is the North American subsidiary of Immundiagnostik AG, specializing in reliable in vitro diagnostic detection tools. They provide immunoassays, including various ELISA kits, and chemiluminescent analyzers to clinical and research laboratories. The company also offers assay validation assistance and custom bulk packaging services.

Innovative Health Diagnostic (IHDLab) manufactures FDA-approved diagnostic panels for donor screening, fertility, and IVF testing. Based in Irvine, CA, the company offers comprehensive lab testing and at-home services, providing timely and accurate health insights for individuals and partners as a trusted laboratory provider.

InBios International, Inc. manufactures immunodiagnostics for infectious diseases. Based in Seattle, WA, the company provides FDA-cleared respiratory diagnostics, including CLIA-waived COVID-19 and Flu A&B tests. They also develop diagnostics for emerging diseases and offer contract manufacturing services, with all products made in the USA.

Invitae offers advanced genetic testing services, partnering with Labcorp to provide accessible genetic data and personal health insights. The company specializes in delivering precise care and integrating genetic testing into routine healthcare, serving over 5 million patients and their providers.

Based in Anaheim, CA, IVD Technologies, Inc. is a biotechnology company established in 2005. They manufacture and develop in vitro diagnostic (IVD) products. Offerings include ELISA test kits for H. pylori antigen and Interleukin-6, alongside reagents for chemistry analyzers like Progesterone and Cortisol.

Based in Atlanta, GA, LetsGetChecked manufactures and distributes at-home sample collection kits for health testing. The company operates a CLIA-certified laboratory for analysis, providing comprehensive testing, consultations, and medication directly to individuals and over 5000 organizations.

Based in Santa Clara, CA, Lin-Zhi International, Inc. specializes in the research, development, and manufacturing of diagnostic reagents. They develop innovative and quality products for clinical diagnostics, with a primary focus on drugs of abuse. The company is committed to continual improvement and provides technical support.

Based in Irvine, CA, mdxhealth develops and commercializes molecular diagnostic solutions for urologic diseases, primarily focusing on prostate cancer. The company provides non-invasive tests such as ExoDx Prostate Test, Confirm mdx, and Genomic Prostate Score for personalized risk assessment and earlier detection of aggressive disease.

Meridian Bioscience, based in Cincinnati, OH, manufactures critical reagents and solutions for the in vitro diagnostics industry. The company specializes in antibodies, antigens, blockers, and molecular diagnostic reagent solutions, serving the needs of diagnostic manufacturers worldwide. They are dedicated to delivering precise answers through their advanced diagnostic components.

Based in Vancouver, WA, Molecular Testing Labs specializes in molecular diagnostics, building and supplying test kits for direct-to-patient shipment or to distribution centers. The laboratory also processes a high volume of clinically and non-clinically collected samples, contributing to diagnostic access on a molecular level.

More Diagnostics manufactures in vitro diagnostic controls for clinical laboratories and manufacturing partners. Based in Los Osos, CA, the company specializes in developing precise quality controls for accurate laboratory testing, including OEM applications. They are ISO 13485:2016, MDSAP, FDA, CMDR, and ANVISA certified.

Myriad Genetics develops and commercializes genetic tests and precision medicine solutions for hereditary cancer, prenatal health, oncology, and mental health. Based in Salt Lake City, UT, the company provides diagnostic and prognostic insights that help detect, treat, and prevent various diseases through advanced in vitro diagnostic technologies.

Natera develops and provides advanced cell-free DNA tests dedicated to oncology, women’s health, and organ health. Their noninvasive molecular diagnostic tests measure fetal, tumor, or donor cfDNA to inform personalized healthcare decisions, detect disease risk, evaluate treatment response, and identify organ injury early.

Based in Dayton, OH, Norwood Medical specializes in precision medical device manufacturing and medtech innovations. The company offers post-processing and assembly services, serving demanding markets including cardiovascular, minimally invasive surgery, orthopedics, robotic-assisted surgery, and general surgical technologies.

Based in Austin, Nuclein, LLC manufactures in vitro diagnostic (IVD) solutions. They specialize in the DASH Rapid PCR System, an FDA-cleared and CLIA-waived point-of-care device delivering lab-quality SARS-CoV-2 and Flu A/B test results in 15 minutes. Nuclein focuses on driving innovation in diagnostic testing.

Based in Tustin, CA, Pangea Laboratory is a CLIA-certified and CAP-accredited diagnostics company. It provides end-to-end services from R&D to market launch for diagnostic tests, partnering with diagnostic developers to bring breakthrough IVD products to market. Their services include integrated NGS capabilities, bioinformatics, and regulatory support for oncology and infectious disease assays.

Based in Santa Fe Springs, CA, Pro-Tech Design & Manufacturing offers comprehensive contract packaging, assembly, and outsourcing services for medical devices. They provide sewn medical products, laboratory services, and sterilization solutions. The company is FDA and ISO 13485 registered, with over 40 years of experience and multiple US facilities.

Pyxis Laboratories Inc. specializes in manufacturing high-quality immunoassay reagents for the diagnostic, pharmaceutical, environmental, and biotech industries. Based in the USA, their product offerings include drug protein conjugates and monoclonal antibodies. They provide essential components for various scientific and medical applications.

Based in San Diego, CA, QuidelOrtho manufactures in vitro diagnostic (IVD) systems and tests, providing vital health information. The company delivers real-time, actionable intelligence with platforms like VITROS, SOFIA, and ORTHO Workstation, transforming diagnostic data into clinical action for various healthcare settings.

Based in Bland, MO, Roberson Machine Company is a US-based contract manufacturer specializing in precision CNC machining. They offer milling, turning, wire EDM, and 3D printing services, from prototype to production. The company provides reliable manufacturing for industries including medical devices, oil, and automotive.

ScyTek Biotech Life Sciences, based in West Logan, UT, manufactures a comprehensive range of diagnostic reagents. They produce Special Stains, Antibodies, and buffers. The company specializes in supplies for Hematology, Immunohistochemistry, and Microbiology, supporting critical needs for in vitro diagnostics and life science applications.

Based in San Diego, CA, Sekisui Diagnostics is a global partner specializing in the innovation and development of highly accurate diagnostics and biochemistry products. They supply materials for biotherapeutic manufacture, pharmaceutical production, diagnostic reagents, biosensors, and medical devices.

Solventum, a standalone company spun off from 3M's healthcare business, develops and manufactures advanced molecular and medical diagnostics. They focus on creating new ways to deliver better, faster tests for patients, building on a history of diverse healthcare product offerings and innovations.

Spartronics provides electronic contract manufacturing and assembly services for highly-regulated, complex products. Specializing in medical device and life science manufacturing, it offers FDA-registered contract manufacturing, PCBA, subsystem integration, and full-box builds across various markets.

Strukmyer Labs, based in Lake Oswego, OR, provides contract manufacturing for custom medical devices, instrumentation, and analytical equipment. Operating from a BSL-2 compliant facility, they guide clients from concept to commercialization. They focus on delivering innovative, low-cost, and eco-friendly solutions for device development.

Based in Anaheim, CA, Teco Diagnostics specializes in manufacturing private-label, FDA-registered, and CE-marked over-the-counter medical test kits. They provide comprehensive IVD solutions, including urinalysis, rapid tests, clinical chemistry, and instrumentation, supporting IVD companies with R&D and production for global market entry.

Based in Carlsbad, CA, True Diagnostics develops and manufactures innovative tests and products. The company assists physicians by providing solutions for preventing, diagnosing, and treating various medical conditions. They focus on creating advanced diagnostic tools for healthcare.

Diasorin is a global leader in the laboratory diagnostics market, specializing in immunodiagnostics and molecular diagnostics. The company develops and manufactures advanced solutions, including LIAISON® systems and assays, to empower faster, more accurate triage for infection decisions and reduce unnecessary antibiotic use.

Based in South San Francisco, CA, Veracyte Inc. specializes in developing and commercializing advanced genomic tests for various cancers, including thyroid, prostate, bladder, breast, and lung. The company provides clinicians with comprehensive diagnostic insights to inform personalized treatment plans and advance precision cancer care.

Based in Sierra Madre, CA, Zeta Corporation is a biomedical company manufacturing IVD antibodies. With ISO 13485 and FDA certifications, they develop diagnostic products and antibody cocktails primarily for various cancers including lung, breast, and ovarian, alongside dermatopathology applications.

Fulgent Genetics specializes in clinical diagnostic genetic sequencing, offering over 18,000 tailored tests. The company provides actionable genetic insights for better patient care, focusing on the development and execution of a wide range of in-vitro diagnostic genetic tests.

Based in Hayward, CA, Hipro manufactures point-of-care IVD products. The company engages in R&D, manufacturing, and marketing of accurate diagnostic systems, including instrumentation, reagents, and data management. Hipro's biotechnology products and services are distributed in over 100 countries.

Based in San Francisco, CA, HORIBA Medical manufactures comprehensive in vitro diagnostic (IVD) systems. They provide extensive solutions for hematology, hemostasis, and clinical chemistry, including analyzers, reagents, and consumables. These systems serve diverse users, from laboratories to university hospitals.

Based in North Attleboro, MA, HTI Diagnostics manufactures in-vitro diagnostic (IVD) hematology and chemistry analyzers and reagents. Their laboratory analyzers are engineered for challenging real-world conditions, ensuring accurate results for tests like CBC, electrolyte, ELISA, urinalysis, and coagulation in clinical laboratories.

NeoGenomics Laboratories is an oncology diagnostics company transforming cancer care. They develop and provide over 500 in vitro diagnostic tests, including genomic profiling, IHC, FISH, and NGS. Their advanced tissue-based and liquid biopsy solutions deliver precise, actionable insights for personalized patient care.

PreciGenome offers custom design and OEM solutions for In Vitro Diagnostic (IVD) instruments and medical devices, including PCR machines. They specialize in nanoparticle synthesis systems and provide GMP production for lipid nanoparticles. The company delivers scalable, regulatory-compliant manufacturing solutions from prototyping to high-volume production.

QIAGEN is a global provider of Sample to Insight solutions, specializing in molecular testing. The company develops and manufactures fully automated digital PCR systems and assays tailored for IVD applications, enhancing diagnostic precision. QIAGEN's product portfolio also includes instruments and software for life science research and applied testing, with significant operations in the United States.

Based in Newton, MA, Sherlock Biosciences develops proprietary platforms and diagnostic tools for rapid, accurate, and affordable DNA and RNA detection. Leveraging CRISPR and synthetic biology, the company creates point-of-need molecular diagnostics, aiming to personalize healthcare and improve global health outcomes.

Siemens Healthineers USA specializes in manufacturing in-vitro diagnostic (IVD) solutions. They provide rapid, convenient, and easy-to-use diagnostic testing technologies for various healthcare settings, including emergency departments and physician offices. These solutions enhance diagnostic quality, accelerate results, and improve overall patient care.

Texas Biogene is a global molecular diagnostics company that specializes in the development, manufacture, and marketing of nucleic acid testing kits and related services. Based in Houston, TX, the company provides essential solutions for molecular diagnostics, supporting healthcare and research with advanced testing capabilities and products.

Based in Richmond, TX, Velentium Medical designs and manufactures Class II and Class III medical devices. The company is a professional engineering firm, transforming intellectual property into safe and secure products. Their core services include medical device R&D, manufacturing, cybersecurity, and test systems.

Based in Chicago, IL, Abbott is a global healthcare company specializing in the development and manufacture of innovative medical devices and healthcare solutions. They provide products for cardiovascular health, diabetes management, and diagnostic testing, including in vitro diagnostics, serving diverse healthcare needs worldwide.

Advin Biotech is a U.S. manufacturer of premium quality in vitro diagnostic tests, including customized drug tests (urine and oral fluid), COVID-19 antigen tests, and COVID-19/Flu A&B rapid tests. Based in San Diego, CA, they leverage innovative R&D and U.S. manufacturing capabilities, offering private labeling and co-branding partnerships.

Alamar Biosciences, based in Fremont, CA, is a proteomics company developing and manufacturing high-sensitivity protein analysis tools and nELISA™ technology. They provide innovative solutions for protein biomarker detection, catering to life science research, clinical diagnostics, and precision medicine applications. The company focuses on advancing quantitative protein analysis.

Ansh Labs specializes in developing and manufacturing validated immunoassays ELISA for biomedical research and clinical diagnostics. They offer highly specific assays with excellent sensitivities and long shelf lives, leveraging in-house antibody development and characterization. Part of the VION Biosciences family, Ansh Labs is committed to advancing diagnostic capabilities.

Based in Carlsbad, CA, Argonaut Manufacturing Services specializes in contract manufacturing for the life sciences and IVD sectors. They provide comprehensive services including aseptic and non-aseptic fill finish, lyophilization, and analytical and QC support, operating from their extensive manufacturing facilities.

Based in Springville, UT, Arlington Scientific (ASI) manufactures bulk latex serology reagents and RPR (Rapid Plasma Reagin) offerings for in vitro diagnostic (IVD) applications. As a US FDA Registered company, ASI provides essential components to healthcare companies seeking to enhance their diagnostic capabilities.

Based in Durham, NC, Avioq, Inc. is an in-vitro diagnostic (IVD) medical device company specializing in the development, production, and distribution of quality IVD products. They provide flexible contract development and manufacturing services from their FDA-licensed and ISO 13485 certified facility, supporting all phases of IVD product development.

Based in Hercules, CA, Bio-Rad develops and manufactures a wide range of products for the life science research and clinical diagnostic markets. The company provides essential solutions for in vitro diagnostics, serving the needs of the healthcare and research industries with its comprehensive offerings.

Based in Sterling, MA, BMP Medical specializes in custom medical plastics manufacturing, offering injection molding, injection blow molding, and precision assembly for OEMs. They co-develop scalable, high-quality components and devices, including IVD components, ensuring reliable manufacturing solutions for the medical industry.

Based in Monrovia, CA, ChromoLogic LLC specializes in developing point-of-care biomedical solutions. Their expertise spans wound care diagnostics-screening, digital health, and drug delivery systems. The company focuses on creating affordable, optimal health outcomes through innovative diagnostic and therapeutic technologies, serving medical and industrial sectors.

Based in Newbury, OH, DEM Manufacturing is an FDA-registered provider of turnkey product development for medical devices. They specialize in engineering, rapid prototyping, and production, applying Design for Manufacturing (DFM) best practices. Capabilities include custom cabling, PCBAs, 3D printing, and injection molded components for high-precision products.

Based in Fremont, CA, Evolve Manufacturing specializes in the production of complex medical and life sciences devices and instruments. Operating from a 75,000 sq ft facility in Silicon Valley, the company offers comprehensive manufacturing services for advanced diagnostic and research tools.

Based in Madison, WI, Exact Sciences develops innovative in vitro diagnostic tests for cancer prevention, early detection, screening, and therapy guidance. The company offers solutions like Cancerguard, a multi-cancer early detection test, and provides genomic testing to inform personalized cancer treatment pathways and improve patient outcomes.

Based in Grand Rapids, MI, Fortis Life Sciences is a contract development and manufacturing organization (CDMO) for life science and diagnostics companies. They provide an integrated portfolio of diagnostic assay CDMO services, including antibodies for clinical diagnostics, diagnostic components, enzyme & master mix CDMO, and lyophilization services.

Freudenberg Medical is a CDMO providing end-to-end support for medical devices and pharmaceutical innovations. Serving the IVD market, they offer services from ideation to full-scale series manufacturing. Their vertically integrated capabilities include precision molding and extrusion, operating from global sites with facilities in Southern California.

GRAIL develops and offers the Galleri multi-cancer early detection (MCED) blood test, an in vitro diagnostic solution. This test screens for various cancers before they become symptomatic, supporting improved patient outcomes through early detection. It is utilized by insurance companies and healthcare providers.

Gold Standard Diagnostics provides comprehensive diagnostic solutions. This company designs and manufactures proprietary instruments and assays for the clinical diagnostics market, including products for COVID-19 and Lyme disease testing.

Guardant Health is a precision medicine company specializing in in vitro diagnostics for cancer. They develop and commercialize advanced blood tests for cancer screening, detection, and recurrence monitoring, leveraging data to transform patient care. The company provides genomic profiling and liquid biopsy solutions.

Immunosciences Lab, Inc. (ISL), based in Santa Fe Springs, CA, is a CLIA-licensed and CAP-accredited clinical reference laboratory and IVD manufacturer. They specialize in developing and manufacturing advanced antibody testing systems for diagnosing autoimmune and infectious diseases, offering proprietary diagnostic solutions.

IMMY Diagnostics is a US-based organization specializing in mycology. The company develops, manufactures, and distributes innovative in vitro diagnostic tests and reagents for fungal diseases. They aim to provide fast, reliable access to fungal disease diagnosis globally.

Based in San Diego, CA, Invivoscribe, Inc. develops and manufactures CE-marked in vitro diagnostic cGMP products for hematology-oncology. With over 30 years of experience, the company specializes in assays for leukemias and lymphomas, pioneering the world's first approved AML CDx and other precision diagnostic solutions.

KRONUS Inc. designs and markets a comprehensive range of immunoassay and autoimmune diagnostic test kits. These in vitro diagnostic (IVD) products are developed to support the assessment of various endocrine and metabolic autoimmune conditions.

Based in San Diego, CA, VedaBio, Inc. develops a breakthrough CRISPR-based molecular detection platform. The CRISPR Cascade™ enables ultra-rapid and highly multiplexed detection of analytes with unparalleled accuracy, without requiring target amplification, suitable for advanced diagnostic applications.

Based in Irwindale, CA, W.H.P.M., Inc. is an In Vitro Diagnostics (IVD) manufacturer. The company specializes in research, development, and production of immunoassay testing kits, including drugs of abuse, automated FIT, and fertility diagnostics. W.H.P.M. provides OEM, private labeling, and contract manufacturing services for partners in the medical diagnostic market.

Agilent Technologies is a global leader providing instruments, software, services, and consumables for life sciences, diagnostics, and applied chemical markets. The company manufactures various products crucial for in vitro diagnostics (IVD), including analytical instruments, reagents, and workflow solutions, enabling labs to deliver precise diagnostic insights.

Beckman Coulter Diagnostics manufactures in vitro diagnostic (IVD) products, enabling healthcare professionals to deliver accurate diagnostic information. The company focuses on developing solutions that assist laboratories and clinicians in improving patient care outcomes.

Abbott Diagnostics develops point-of-care and core laboratory diagnostic solutions addressing critical health needs like cardiology, infectious disease, and toxicology. The company focuses on building reliable tools and expanding efforts to respond quickly to global health threats.

Foundation Medicine specializes in precision medicine, developing and providing in vitro diagnostic tests for advanced cancer. They offer expert support for drug development, from discovery to launch, and integrate into EMRs to enhance clinical workflow efficiency for providers.

iDetekt manufactures advanced lateral flow readers, providing digital platforms for rapid diagnostics. These readers are utilized in lab and field environments globally, supporting diverse sectors including agriculture, pharmaceutical research, food & beverage, environmental monitoring, and medical applications.

In Vitro Diagnostic Solutions specializes in developing point-of-care platforms for novel biomarkers. They provide contract work for assay development and engineering services, supporting companies in bringing innovative in vitro diagnostic products to market. Their expertise covers various aspects of IVD product realization.

Abbott Molecular develops and manufactures advanced in-vitro diagnostic (IVD) solutions for personalized healthcare. Their offerings include FDA-approved self-collection devices, such as simpli-collect™ kits for HPV and STI screening, enhancing access to vital testing. They also provide sophisticated molecular diagnostic instruments for infectious disease, oncology, and genetics applications.

Phillips Medisize operates as a contract development and manufacturing organization (CDMO). The company specializes in engineering and manufacturing consumables and cartridges for leading pharmaceutical, medtech, and in vitro diagnostic companies. They provide design and manufacturing expertise to clients across the US, Europe, and Asia.

Scorpius BioManufacturing is a contract development and manufacturing organization (CDMO) specializing in biologics. Operating a modern facility in San Antonio, Texas, the company offers cGMP manufacturing services, alongside analytical and process development, and fill/finish capabilities. It serves various biopharmaceutical sectors, providing essential components and manufacturing solutions.

Thermo Fisher Scientific offers OEM and contract manufacturing services specifically for in vitro diagnostic (IVD) products. The company supports large IVD suppliers with high-performance antibodies, advanced validation solutions, and specialized reagents, aiding in diagnostic development and maximizing lab efficiency. They fuel innovation.

Viant Medical specializes in complex electromechanical assemblies, thermoforming, and finished device manufacturing for leading medical device OEMs. The company offers comprehensive design, development, and manufacturing capabilities for various clinical markets, including interventional and inhalation devices, moving MedTech forward.

VitalScientific manufactures benchtop clinical chemistry analytical systems and comprehensive laboratory solutions. They provide analyzers, ready-to-use reagents, calibrators, controls, and ISE for small to mid-sized clinical laboratories, aiming to enhance global healthcare with high-quality, cost-efficient solutions.