In US and Canada: For Research Use Only. Not for Use in Diagnostic Procedures.

BIOPHEN™ Heparin LRT is a one-stage, kinetics anti-Xa chromogenic assay for measuring the concentration of anticoagulants in human citrated plasma. Liquid, ready-to-use — no reconstitution required. Measures: Unfractionated Heparin (UFH), Low Molecular Weight Heparins (LMWH: enoxaparin, dalteparin, tinzaparin, nadroparin), Fondaparinux (Arixtra®), Danaparoïd (Orgaran®), AND Direct Oral FXa Inhibitors: Rivaroxaban (Xarelto®), Apixaban (Eliquis®), Edoxaban (Savaysa®/Lixiana®). Method: Patient plasma + bovine FXa (R1) ? residual FXa measured with chromogenic substrate (R2). Uses endogenous patient antithrombin. One-stage kinetics method — results in minutes on automated analyzers. Calibrators (drug-specific, order separately): UFH Calibrator (222301), LMWH/Heparin Calibrator (222001), Fondaparinux/Arixtra® Calibrator (222501), Rivaroxaban Calibrators (226001/226101/226201), Apixaban Calibrators (226401/226501), Edoxaban Calibrator (222701). Controls (drug-specific): UFH Control (223101), LMWH Control + LMWH Control Low (223001/223701), Fondaparinux Control (224001), Rivaroxaban Controls (225101/225301), Apixaban Controls (224501/225401/225501), Edoxaban Controls (222201/223501). Dilution buffer: Tris-NaCl-EDTA pH 7.85 (AR032K) — EDTA chelates Ca²? to prevent sample degradation. Compatible analyzers: Sysmex CA/CS/CN, Werfen ACL TOP® Family, Stago STA-R®. 510(k) cleared (via calibrator clearances). CE-IVD. 4x7.5 mL.