Blood Analyzers in Indiana

R² Diagnostics, Inc. is an FDA 21 CFR Part 820-registered and ISO 13485-certified manufacturer and distributor of hemostasis diagnostic reagents and controls for clinical coagulation laboratories. Founded in 1993 as a sister company of Enzyme Research Laboratories (ERL), the company specializes in end-to-end controlled manufacturing of high-purity coagulation testing products. Product portfolio includes liquid thromboplastins (Phosphoplastin RL, low ISI), activated partial thromboplastin time reagents (Phospholin ES, heparin and lupus sensitive), Protein S kits (ThromboTek PSe, 24-hour reconstituted stability), kaolin-activated contact factor reagents (LupoTek KCT), lupus anticoagulant screening and confirmation reagents (LupoTek Detectin VL, LupoTek Correctin VL), thrombin time assays (T-Tek), and fibrinogen measurement kits (Fibro Tek) manufactured with human thrombin from ERL. The company leverages high-purity proteins and reagents supplied by sister company Enzyme Research Laboratories, enabling tight process control and quality assurance throughout manufacturing. Products are designed for use on automated coagulometers and manual coagulation analyzers in hospital and reference laboratories. The company serves clinical laboratory directors, hemostasis specialists, and laboratory professionals managing bleeding disorder diagnostics and anticoagulation monitoring.

PTS Diagnostics is a manufacturer of point-of-care diagnostic testing systems specializing in lipid panel, blood glucose, and A1C testing. The company designs portable, battery-powered analyzers intended for deployment across diverse clinical settings including physician offices, pharmacies, mobile health clinics, hospitals, universities, workplaces, and home settings. Their core products—CardioChek® for lipid testing and A1CNow® for A1C measurement—deliver test results in minutes using CLIA-waived methodology. Test strips and cartridges operate at room temperature without refrigeration requirements. All analyzers meet national standards for accuracy and precision. PTS Diagnostics also manufactures the PTS Connect® family of data management products (Blu-Adapter, Blu-Dock, Printer) enabling integration and result sharing across healthcare environments. The company positions its solutions for accessibility in diabetes management, cardiovascular disease risk assessment, self-testing, home health services, community health programs, occupational health screening, and pediatric applications. Products are designed for minimal storage footprint and lightweight portability. The company provides online training and direct customer support, operating Monday–Friday, 8 a.m.–8 p.m. EST.

Roche Diagnostics is a global leader in in vitro diagnostic (IVD) instruments, assays, and laboratory systems for clinical chemistry, molecular diagnostics, pathology, and specialty testing. The company manufactures high-volume automated analyzer platforms including the cobas® c 703 for clinical chemistry (2,000 tests/hour), cobas® 5800 system for consolidated automation and integration, and Digital LightCycler® System for digital PCR applications. Product offerings span core lab chemistry, hematology, immunochemistry, mass spectrometry solutions (including Ionify® steroid assays), tissue diagnostics with ready-to-use oncology assays, and blood-based biomarker testing (e.g., pTau181 for Alzheimer's-related amyloid pathology). The organization serves laboratory professionals, clinicians, researchers, and patients across multiple laboratory settings. Roche maintains FDA clearances and 510(k) approvals for its analytical systems and assays, with CLIA moderate-complexity categorization for specialized tests. The company provides comprehensive support including eLabDoc document library access (800,000+ documents), e-learning platforms, PACE/CEU accredited training, and clinical education resources. Manufacturing and regulatory operations are supported from US facilities including Indianapolis headquarters.