Blood Analyzers in California

Guardant Health is a precision oncology company specializing in blood-based liquid biopsy testing for cancer detection, staging, and treatment monitoring. The company develops and commercializes circulating tumor DNA (ctDNA) tests that enable early cancer screening and inform treatment decisions across all stages of disease. Their primary product lines include Shield (cancer screening via blood test), Guardant Complete (advanced cancer oncology testing), and BioPharma Solutions for drug development and clinical trials. With over 500,000 tests performed and 12,000 physicians utilizing their platform, Guardant Health provides data-driven insights to improve clinical outcomes through biomarker analysis and minimal residual disease (MRD) detection. The company operates a CLIA-certified laboratory in the Bay Area and maintains regulatory compliance for commercialized diagnostics. Their technology supports personalized cancer care by identifying genetic mutations, tumor characteristics, and treatment response markers from blood samples, reducing reliance on invasive tissue biopsies and enabling earlier intervention.

Diagnostic Automation / Cortez Diagnostics, Inc. (DACD) is a global diagnostic test kit manufacturer founded in 1989, serving research labs, hospitals, clinical laboratories, and physicians across 168 countries. The company specializes in producing ELISA kits, rapid test kits, chemiluminescence immunoassay (CLIA) kits, serology tests, and immunofluorescence assay (IFA) kits. DACD offers both consumable diagnostic test kits and associated instruments for clinical laboratory use. The product portfolio addresses infectious disease serology, immunological testing, and general clinical diagnostics. The company emphasizes quality assurance, competitive pricing, fast shipping, and technical customer support. DACD maintains manufacturing and distribution operations from its Woodland Hills, California headquarters and distributes globally through a network of respected distributors. The company is privately held and committed to continuous innovation in diagnostic testing methodologies.

Monobind Inc. is a leading independent in vitro diagnostics (IVD) manufacturer founded in 1978 and headquartered in Lake Forest, California. The company develops and manufactures over 160 immunoassay products across its AccuBind® ELISA and AccuLite® CLIA platforms, serving clinical laboratories, point-of-care facilities, and direct-to-patient applications globally. Monobind's portfolio spans multiple assay formats—microplate, monotest, magnetic-bead, lateral flow assays (LFA), and microarray technologies—enabling testing of serum, plasma, and whole blood samples. The company supports scalable workflows from manual reader-based systems to fully automated random-access analyzers. Beyond finished assays, Monobind supplies high-quality biomaterials and specialty reagents including buffers and stabilizers for the global diagnostics industry. Operating under FDA registration and ISO 13485 certification, the company distributes CE-marked products to laboratories and partners in over 100 countries worldwide.

Beckman Coulter Diagnostics is a global leader in clinical diagnostics and biomedical testing, headquartered in Brea, California. A subsidiary of Danaher Corporation since its foundational 1935 establishment, the company develops, manufactures, and distributes innovative laboratory automation systems, analyzers, and informatics solutions for clinical and research laboratories worldwide. The company specializes in clinical chemistry systems, immunoassay instruments, hematology analyzers, urinalysis systems, microbiology solutions, blood banking instruments, and protein chemistry platforms. Beckman Coulter also provides total lab automation systems (DxA 5000 series), advanced informatics middleware (Remisol Advance), and remote diagnostic services. Its comprehensive portfolio supports healthcare professionals and laboratory teams in disease diagnosis, treatment decisions, patient monitoring, and improved health outcomes. With annual revenue of approximately $2.9 billion, the company emphasizes efficiency, automation, clinical confidence, and integrated workflow solutions for hospital laboratories, reference laboratories, and blood banks globally.

Since 1986, Jant Pharmacal Corporation has been a leading B2B supplier of point-of-care (POC) diagnostic tests and laboratory instrumentation to U.S. and international healthcare settings. The company operates two primary divisions: POC Division and Lab Division. The POC Division offers CLIA-waived rapid tests and analyzers for use in physicians' offices, clinics, urgent care centers, and hospitals under registered trademarks Accutest, Accustrip, and LipidPlus. Product categories include cardiac testing, colorectal cancer screening, drugs of abuse, hypothyroidism, infectious diseases, pregnancy & fertility, and urinalysis. The Lab Division provides integrated solutions for laboratory optimization, featuring clinical chemistry, hematology, immunoassay, toxicology, urinalysis, and molecular diagnostic systems with reagents and consumables. The company holds GPO supplier contracts with Vizient and Champs, representing over 500,000 members. Additionally, Jant offers laboratory consultation services including financial feasibility assessment, turn-key laboratory setup, CLIA compliance consultation, LCMS method development, and laboratory information system integration.

Biobase Biodustry (Shandong) Co., Ltd is a high-tech manufacturer founded in 1999, headquartered in Jinan, Shandong, China. The company operates 25 manufacturing facilities and provides comprehensive one-stop solutions for laboratory, medical, and clinical applications. Core product categories include biological safety cabinets, laminar flow cabinets, fume hoods, sterilization equipment (autoclaves, sterilizers), clinical and analytical instruments (auto chemistry analyzers, electrolyte analyzers, blood bank refrigerators), flow cytometers, PCR cabinets, laboratory cryogenic refrigeration units, and hospital furniture (beds, wheelchairs). Biobase serves research institutions, clinical laboratories, diagnostic facilities, and healthcare providers across more than 190 countries. The company maintains in-house R&D (100+ employees), sales (200+ employees), and after-sales support teams (11+ employees). Certifications include ISO 9001, ISO 13485, ISO 14001, CE, FDA, NSF, SGS, and EN standards, reflecting compliance with international quality and medical device regulations. Services include 24-hour online customer support and warranty coverage for defective components.

MedicalSystem Biotechnology Co., Ltd. is a global in-vitro diagnostics (IVD) solution provider founded in Ningbo, China, in 2003. The company operates a complete value chain from R&D through commercial services, serving clinical laboratories, hospitals, and diagnostic centers across 100+ countries. With ~2,500 employees globally and 22+ years of IVD experience, MedicalSystem specializes in automated clinical laboratory analyzers for biochemistry, chemiluminescence immunoassay, and blood lipid subfraction analysis. Primary product lines include the MS-380P (compact fully-automated chemistry analyzer), MS-i2280 (chemiluminescence immunoassay system integrating reagents and instruments), and VAP Series (advanced analyzers for cardiovascular risk assessment via lipid subfractionation). The company emphasizes reliable, easy-to-use diagnostic solutions designed for continuous laboratory operations. Products combine instrumentation with reagents to support accurate clinical decision-making across diverse laboratory settings. Manufacturing and service capabilities span R&D, production, quality assurance, and after-sales support. No specific FDA 510(k), CE, or ISO certifications are stated on the fetched content, though the company's international distribution and regulatory compliance are implied by presence in 100+ countries.

Acro Biotech, Inc. is a medical diagnostics manufacturer based in Montclair, California, specializing in point-of-care and clinical laboratory testing solutions. The company develops and distributes a diverse portfolio of diagnostic analyzers and rapid testing systems across multiple therapeutic and clinical domains. Product lines include respiratory infection rapid tests (COVID-19 and other respiratory panels, though COVID tests are not FDA-cleared for US distribution), drugs of abuse screening tests, cardiac biomarker assays, urine analyzers, fluorescence immunoassay analyzers, and multiparameter handheld meters for hemoglobin, cholesterol, uric acid, and glucose testing. The company also offers solutions for women's health, infectious disease serology, tumor markers, and veterinary diagnostics. Key analyzer platforms include the ATR-ACO300 urine analyzer, AFR-600 fluorescence immunoassay system (Apoti), AHR-100 multiparameter meter for hemoglobin/cholesterol/uric acid/glucose, and LF Reader systems. The company serves clinical laboratories, point-of-care testing facilities, and veterinary markets with rapid testing and automated laboratory equipment. No specific FDA 510(k) clearances, ISO certifications, or CE Mark designations are stated on the website. Manufacturing capabilities and regulatory status for products marketed outside the US are not detailed in available content.

CareDx is a transplant-focused diagnostic and digital health company providing comprehensive solutions across the entire transplant journey. The company delivers advanced diagnostics including rejection monitoring tests and HLA typing kits, digital health platforms, and transplant pharmacy services. CareDx reports performing over 1 million rejection monitoring tests annually, selling approximately 200,000 HLA typing kits per year, and filling 150,000 prescriptions through its transplant pharmacy division. The platform serves approximately 70% of transplant centers with one or more software products. Products and solutions span diagnostic testing, digital workflow platforms, lab innovations, and clinical decision support tools. The company combines laboratory testing capabilities with software platforms designed to simplify clinical workflows and personalize patient care throughout transplant management. CareDx operates as an integrated provider offering both diagnostic services and digital health infrastructure for transplant programs, including pre-transplant evaluation, post-transplant monitoring, and rejection surveillance.

LumiQuick Diagnostics Inc. is a minority-owned, privately-held manufacturer of high-quality point-of-care testing and immunoassay kits for the global in vitro diagnostics market. Founded in 2006 and based in Santa Clara, California, the company develops rapid diagnostic tests in multiple formats including test cups, cards, dip tests, and multi-panels. Product lines span infectious disease detection (Dengue, Zika, Chikungunya, COVID-19), drugs of abuse screening, disease markers for cardiac and cancer indicators, fertility hormones, vitamin D assessment, oxidative stress measurement, veterinary diagnostics, food safety testing, and biological threat agent identification. LumiQuick's QuickProfile™ branded assays leverage immunochromatographic technology for qualitative and quantitative detection. The company also manufactures ELISA-based platforms and offers the FDA EUA-cleared Boson Rapid SARS-CoV-2 Antigen Home Test. Products are sold in bulk through local and international distributors, targeting clinical laboratories, point-of-care settings, and compliance screening applications.

Cliawaived, Inc. is a CLIA-waived medical testing and diagnostic supplies distributor serving clinical labs, physician offices, and home-use markets. The company supplies a broad range of point-of-care (POC) testing products including rapid drug screening tests (drug test cards and cups), infectious disease diagnostics (COVID-19, flu, RSV, mono, strep testing), STD/sexual health testing kits, urinalysis consumables, women's health tests, and general medical supplies. Product portfolio includes analyzers and meter devices (glucose monitors and similar POC analyzers), distributed under partnerships with established manufacturers such as Quidel. The company operates an e-commerce platform enabling B2B procurement of CLIA-waived test kits and supplies for clinical settings and direct-to-consumer home testing products. As a distributor of CLIA-waived diagnostics, Cliawaived serves urgent care centers, physician offices, occupational health programs (workplace drug screening), clinical laboratories, and patients seeking over-the-counter diagnostic testing. All products are CLIA-waived, meeting regulatory thresholds for simple test methodology and low clinical risk. The company maintains inventory of consumables and point-of-care instrumentation to support rapid deployment and same/next-day fulfillment for high-volume testing operations.

Grifols is a leading global biopharmaceutical and healthcare company founded in 1909, headquartered in Barcelona with significant US operations. The company operates across four primary business divisions: Biopharma (plasma-derived medicines and biopharmaceuticals for immunology, hepatology, intensive care, pulmonology, hematology, neurology, and infectious diseases), Diagnostic (blood screening and transfusion medicine diagnostics), Bio Supplies (plasma collection and processing supplies), and Healthcare Solutions for Hospitals (hospital equipment and consumables). Grifols manufactures and distributes innovative plasma-derived therapeutic products, clinical laboratory equipment and reagents, diagnostic assays, and healthcare infrastructure solutions for hospital and transfusion medicine settings. The company operates a global plasma donation center network and engages in research and development across multiple therapeutic areas, including immunological disorders, rare diseases, and infectious disease screening. Grifols maintains regulatory compliance with FDA approvals (evidenced by recent malaria blood screening assay approval), ISO standards, and international quality certifications. The company serves healthcare systems, blood banks, hospitals, clinical laboratories, and patients globally, with established operations and partnerships across the Americas, Europe, and Asia-Pacific regions.

TECO Diagnostics is a US-based manufacturer of in vitro diagnostic (IVD) test kits and instrumentation headquartered in Anaheim, California, with 30+ years of experience serving over 100 countries. The company operates as an OEM and private-label partner, developing and manufacturing FDA-registered, CE-marked diagnostic products for global distribution. Product lines include urinalysis test strips, rapid diagnostic tests (including alcohol test strips), clinical chemistry reagents, women's health diagnostics, serology testing, animal health products, and laboratory instrumentation. The facility is cGMP-compliant, ISO 13485:2016 certified, and SA 8000 certified. TECO partners with major retailers including Walmart, Amazon, CVS, and Target. The company offers two business models: custom-branded OEM manufacturing for partners seeking private-label solutions, and direct distribution of established product lines. Their strategy team provides R&D support, product troubleshooting, and market-entry consultation. All products meet American manufacturing and quality standards with regulatory clearance for US and international markets.

Canon Medical Diagnostics USA is a global leader in multiplex allergy in vitro diagnostics. The company manufactures and distributes the OPTIGEN® Allergen-Specific IgE Assay, a comprehensive panel test designed for environmental and food allergen detection in clinical laboratory settings. The product line includes the AP3600™ Automated Instrument, a fully automated diagnostic platform for allergen-specific IgE testing, and the CLA-1™ Luminometer, a sensitive detection system for in vitro allergy diagnostics. These instruments and assays enable healthcare providers to deliver quality allergy care in a timely and cost-effective manner. The company serves clinical laboratories, allergology practices, and hospital laboratory systems. Products are designed for high-throughput multiplex testing of allergen-specific immunoglobulin E (IgE) antibodies, supporting diagnostic protocols in environmental and food allergy evaluation. Canon Medical Diagnostics USA operates from Mountain View, California, and maintains regulatory compliance with clinical laboratory diagnostic standards.

Glycominds Diagnostics is a clinical laboratory diagnostics company specializing in non-invasive biomarker-based solutions for gastrointestinal diseases. The company develops and offers blood-based diagnostic tests for detection, prognosis, and monitoring of inflammatory bowel diseases (IBD), including Crohn's disease and Celiac disease. Product portfolio includes biomarkers for IBD diagnosis, Crohn's disease prognosis assessment, and monitoring of mucosal healing and anti-TNF therapy response. Glycominds positions its offerings as cost-effective alternatives to invasive diagnostic techniques such as endoscopy, providing gastroenterologists and primary care providers with accurate, non-invasive options for patient stratification and treatment monitoring. The company serves healthcare providers managing patients with gastrointestinal inflammatory conditions across multiple care settings.

Antibodies Incorporated is a research-focused supplier of validated antibodies and assay reagents serving academic, biotech, and industrial research markets. The company aggregates products from multiple branded divisions: NeuroMab (primary monoclonal antibodies), Aves Labs (chicken polyclonal and recombinant chimeric antibodies), PhosphoSolutions (rabbit phosphospecific antibodies), ImmunoChemistry Technologies (cell viability assays, ELISA kits, IHC reagents), Biosensis (ELISA kits, antibodies, dyes, tracing reagents), and custom adenovirus production services. Product lines include primary and secondary antibodies, recombinant chimeric antibodies (newly expanded to chicken and guinea pig), phosphospecific antibodies for signaling research, ELISA kits and reagents, immunohistochemistry (IHC) products, cell viability and cytotoxicity assays, adenovirus reagents and custom virus production, and specialized research biochemicals. The company manufactures its products in-house and offers custom antibody development services, including a no-cost antibody production grant for academic and biotech researchers. Distribution is global through an established distributor network. All products are backed by a satisfaction guarantee with returns accepted.

Invivoscribe is a San Diego-based molecular diagnostics company founded in 1995, specializing in precision oncology testing and personalized molecular medicine for hematologic malignancies. The company develops and manufactures CE-marked in vitro diagnostic assays, research-use-only (RUO) assays, analyte-specific reagents (ASRs), and DNA/RNA controls under ISO 13485 design control. Core product lines include next-generation sequencing (NGS) panels for clonality testing (B- and T-cell), minimal residual disease (MRD) assays (LymphTrack®, LeukoStrat® FLT3-ITD and NPM1), and companion diagnostics (CDx) for precision oncology drug therapies. Invivoscribe operates LabPMM®, a CAP-accredited clinical laboratory with multiparametric flow cytometry and molecular testing services, serving clinical laboratories, pharmaceutical companies, and researchers across 160+ countries and 700+ laboratories worldwide. The company also provides bioinformatics software, custom assay development, and turn-key CDx collaboration for pharmaceutical partners, emphasizing regulatory expertise and streamlined drug approval pathways.

HYCOR Biomedical is a global manufacturer and supplier of in vitro diagnostic (IVD) products specializing in blood testing for allergies and immunology. The company operates manufacturing and distribution facilities in Amsterdam (Netherlands), Paris (France), Göttingen (Germany), and Garden Grove (California, USA). HYCOR's primary product line includes the NOVEOS® system, a diagnostic platform for allergy testing. The company serves clinical laboratories, allergists, immunologists, and healthcare facilities worldwide. Their core competency centers on high-quality serological and immunoassay-based diagnostic solutions for allergy detection and management. HYCOR markets its solutions to both institutional laboratories and through a distributor network. The company supports healthcare professionals through educational resources, technical literature, and training on allergy diagnostics and testing methodologies. HYCOR's offerings address the clinical need for accurate, reliable in vitro allergy diagnostics used in patient diagnosis, treatment planning, and immunotherapy monitoring. The company maintains regulatory compliance appropriate for IVD manufacturers in multiple jurisdictions including the United States, European Union, and other international markets.

Epitope Diagnostics Inc. is an ISO 13485:2016 certified and FDA-registered medical device manufacturer specializing in niche immunoassays for clinical diagnostics and research communities. Headquartered in San Diego, California, the company manufactures chemiluminescence immunoassay kits, automated ELISA kits, lateral flow rapid test kits (EPITUUB® US patented), and specialty antibodies. Product portfolios span tumor markers and cancer research, gastrointestinal disease diagnostics, infectious disease testing, cardiovascular disease markers, calcium and bone metabolism assays, endocrinology and diabetes testing, autoimmune disease panels, and anemia diagnostics. The company serves both USA and international markets through separate product catalogs and maintains automation and analyzer platforms alongside traditional immunoassay methodologies. All products are designed for professional laboratory use in clinical and research settings. The company maintains full regulatory compliance with FDA licensing and ISO quality management systems certification valid through June 2026.

Qualigen, Inc. manufactures the FastPack® immunoassay analyzer platform, a point-of-care and laboratory diagnostic system designed for rapid, accurate immunoassay testing in hospitals, clinics, and doctor's offices. The FastPack technology platform specializes in quantitative human chorionic gonadotropin (hCG) testing for women's health diagnostics, with expanding applications in immunoassay testing. The company positions its solutions as quick, simple, and accurate alternatives to traditional laboratory workflows, emphasizing time savings, cost reduction, and improved patient outcomes. Qualigen distributes its analyzers and consumable test kits through group purchasing organization (GPO) partnerships, including recent expansion via Afaxys GPO agreements. The company provides comprehensive customer support including technical assistance, supply ordering, training resources, and safety documentation (SDS). While specific regulatory certifications are not detailed on the primary website content provided, the company operates in the clinical diagnostics space serving hospital and clinic laboratory settings. Manufacturing and service capabilities appear centralized at the Carlsbad, California headquarters location.

ACON Laboratories, Inc. is a US FDA-registered global medical device manufacturer specializing in point-of-care testing (POCT) and immunoassay products. Headquartered in San Diego, California, the company develops and manufactures diagnostic solutions across four primary product lines: Point of Care, Immunoassays, Molecular Diagnostics, and Animal Health. Products serve hospitals, clinical laboratories, physician offices, blood banks, pharmacies, and veterinary clinics worldwide. The On Call® Blood Glucose Meter Family is designed for glucose monitoring and diabetes management. Mission® brand includes urine reagent test strips, urine analyzers, and handheld devices for cholesterol, coagulation, and hemoglobin measurement. HealthyMe® provides urinary tract infection (UTI) detection reagent strips. Flow flex® is the newest lateral flow rapid testing brand, offering multiplexed home tests including the recently FDA 510(k)-cleared Flow flex® Plus RSV + Flu A/B + COVID multiplex rapid antigen test for ages 6 months and up. The company's ACON brand offers lateral flow rapid tests for pregnancy, cancer markers, and infectious disease screening, including SARS-CoV-2 antibody and antigen tests. Distinct® provides pregnancy rapid tests using qualitative chromatographic immunoassays. Foresight® offers allergen immunoblot testing for 30 allergens on a single strip. Promotor® provides nucleic acid extraction systems and PCR quantitative test kits for HBV, HCV, HPV 16/18, HPV genotyping, tuberculosis, and HLA-B27. CentriVet® serves veterinary diagnostics with dual ketone/glucose meters and urine reagent strips. ACON maintains US FDA registration, provides contract manufacturing and OEM services, and holds multiple FDA 510(k) clearances for its diagnostic products.