R2 DIAGNOSTICS, INC.

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.