Hyphen BioMed
BIOPHENâ„¢ Abnormal Control Plasma (RUO)
In US: For Research Use Only. Not for Use in Diagnostic Procedures. Abnormal human plasma for the quality control of assays for Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Prothrombin, Factors VII+X, Factors V, VII, IX, X, XI, XII, Plasminogen, 2-Antiplasmin, PT/INR/%, aPTT, and vWF:Ag. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit. May also be used as negative control for Lupus Anticoagulant.
BIOPHENâ„¢ Abnormal Control Plasma
In EU and Canada: For In Vitro Diagnostic Use. Abnormal human plasma for the quality control of assays for Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Prothrombin, Factors VII+X, Factors V, VII, IX, X, XI, XII, Plasminogen, 2-Antiplasmin, PT/INR/%, aPTT, and vWF:Ag. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit. May also be used as negative control for Lupus Anticoagulant.
BIOPHENâ„¢ Abnormal Control Plasma (IVD)
In US: For In Vitro Diagnostic Use. Abnormal plasma for the quality control of assays for Antithrombin and Protein C. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit.
BIOPHENâ„¢ Normal Control Plasma (RUO)
In US: For Research Use Only. Not for Use in Diagnostic Procedures. Normal human plasma for the quality control of assays for Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Prothrombin, Factors VII+X, Factors V, VII, IX, X, XI, XII, Plasminogen, Act PC-r, 2-Antiplasmin, Thrombin Time, PT/INR/%, aPTT, and vWF:Ag. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit. May also be used as negative control for Lupus Anticoagulant.
BIOPHENâ„¢ Normal Control Plasma
In EU and Canada: For In Vitro Diagnostic Use. Normal human plasma for the quality control of assays for Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Prothrombin, Factors VII+X, Factors V, VII, IX, X, XI, XII, Plasminogen, Act PC-r, 2-Antiplasmin, Thrombin Time, PT/INR/%, aPTT, and vWF:Ag. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit. May also be used as negative control for Lupus Anticoagulant.
BIOPHENâ„¢ Normal Control Plasma (IVD)
510(k) Cleared For In Vitro Diagnostic Use. Normal human plasma for the quality control of assays for Protein C, Antithrombin, and aPC-resistant Factor V (FV-Leiden). The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit.
BIOPHENâ„¢ UFH Control Plasma
In EU: This Product is CE Marked. Health Canada Licensed. Quality control plasmas (2 different levels: about 0.20 and 0.50 IU/mL) for the quality control of UFH testing (Unfractionated Heparin).
BIOPHENâ„¢ UFH Control Plasma
In US: 510(k) Cleared for In Vitro Diagnostic Use. Quality control plasmas (2 different levels: about 0.20 and 0.50 IU/mL) for the quality control of UFH testing (Unfractionated Heparin).
BIOPHENâ„¢ LMWH Control Plasma
In EU: This Product is CE Marked. Health Canada Licensed. Quality control plasmas (2 different levels: about 0.80 and 1.20 IU/mL) for the quality control of LMWH testing (Low Molecular Weight Heparin), in the high concentration range.
BIOPHENâ„¢ LMWH Control Plasma
In US: 510(k) Cleared for In Vitro Diagnostic Use. Quality control plasmas (2 different levels: about 0.80 and 1.20 IU/mL) for the quality control of LMWH testing (Low Molecular Weight Heparin), in the high concentration range.
BIOPHENâ„¢ Dabigatran Calibrator Low
In US: For Research Use Only. Not for Use in Diagnostic Procedures. Lyophilized plasmas, at a defined Dabigatran concentrations (3 levels from 0 to about 120 ng/mL), as measured with the HEMOCLOT Thrombin Inhibitors kit (Ref ACK002K-RUO / ACK002L-RUO), for the calibration of Direct Thrombin Inhibitor assays (clotting or chromogenic) for Dabigatran.
BIOPHENâ„¢ Dabigatran Calibrator Low
In EU: This product is CE Marked. Health Canada Licensed. Lyophilized plasmas, at a defined Dabigatran concentrations (3 levels from 0 to about 120 ng/mL), as measured with the HEMOCLOT Thrombin Inhibitors kit (Ref ACK002K-CAN / ACK002L-CAN), for the calibration of Direct Thrombin Inhibitor assays (clotting or chromogenic) for Dabigatran.
BIOPHENâ„¢ Dabigatran Plasma Calibrator
In US: For Research Use Only. Not for Use in Diagnostic Procedures. Lyophilized plasmas, at a defined Dabigatran concentrations (3 levels from about 50 to 500 ng/mL), as measured with the HEMOCLOT Thrombin Inhibitors kit (Ref ACK002K-RUO / ACK002L-RUO), for the calibration of Direct Thrombin Inhibitor assays (clotting or chromogenic) for Dabigatran.
BIOPHENâ„¢ Dabigatran Plasma Calibrator
In EU: This Product is CE Marked. Health Canada Licensed. Lyophilized plasmas, at a defined Dabigatran concentrations (3 levels from about 50 to 500 ng/mL), as measured with the HEMOCLOT Thrombin Inhibitors kit (Ref ACK002K-CAN / ACK002L-CAN), for the calibration of Direct Thrombin Inhibitor assays (clotting or chromogenic) for Dabigatran.
BIOPHENâ„¢ Rivaroxaban Plasma Calibrator
In US: For Research Use Only. Not for Use in Diagnostic Procedures. Lyophilized plasmas, at defined Rivaroxaban concentrations (3 levels of about 0 to 500 ng/mL), as measured with the BIOPHEN DiXal (Ref A221030-RUO), for the calibration of Rivaroxaban measurements using anti-Xa chromogenic assays.
BIOPHENâ„¢ Rivaroxaban Plasma Calibrator
In EU: This Product is CE Marked. Health Canada Licensed. Lyophilized plasmas, at defined Rivaroxaban concentrations (3 levels of about 0 to 500 ng/mL), as measured with the BIOPHEN DiXal (Ref A221030-CAN), for the calibration of Rivaroxaban measurements using anti-Xa chromogenic assays.
BIOPHEN™ Arixtra® Calibrator
In US: For Research Use Only. Not for Use in Diagnostic Procedures. Range of calibration plasmas (3 sets at 4 different Arixtra levels; 0 to 1.50 g/mL) for the assay of Fondaparinux (Arixtra).
BIOPHEN™ Arixtra® Calibrator
In EU and Canada: For In Vitro Diagnostic Use. Range of calibration plasmas (3 sets at 4 different Arixtra levels; 0 to 1.50 g/mL) for the assay of Fondaparinux (Arixtra).
BIOPHENâ„¢ V-L Plasma Calibrator
In US: 510(k) Cleared for In Vitro Diagnostic Use. Lyophilized, undiluted human plasmas, at defined Factor V-Leiden (FV-L) concentrations, for the calibration of Factor V-L activity quantitative clotting assay on human citrated plasma, using the HEMOCLOT Quanti. V-L kit (ref ACK065K).
BIOPHENâ„¢ UFH Calibrator
In EU: This Product is CE Marked. Health Canada Licensed. Range of calibration plasmas supplemented with Unfractionated Heparin (UFH) (4 sets at 5 different UFH levels; 0 to 1.40 IU/mL) for the assay of Unfractionated Heparin.
BIOPHENâ„¢ UFH Calibrator
In US: 510(k) Cleared for In Vitro Diagnostic Use. Range of calibration plasmas supplemented with Unfractionated Heparin (UFH) (4 sets at 5 different UFH levels; 0 to 1.40 IU/mL) for the assay of Unfractionated Heparin.
BIOPHEN™ Orgaran® Calibrator
In US: For Research Use Only. Not for Use in Diagnostic Procedures. Range of calibration plasmas (4 sets at 5 different Orgaran levels from 0 – to 1.60 U/mL) for the assay of Sodium Danaparoid (Orgaran).
BIOPHEN™ Orgaran® Calibrator
For In Vitro Diagnostic Use. Range of calibration plasmas (4 sets at 5 different Orgaran levels from 0 – to 1.60 U/mL) for the assay of Sodium Danaparoid (Orgaran).
BIOPHENâ„¢ Plasma Calibrator (RUO)
In US: For Research Use Only. Not for Use in Diagnostic Procedures. Calibration plasma for the assay of Protein C, Protein S, Antithrombin, Fibrinogen, Factor VIII:C, Prothrombin, Factors VII+X, Factors V, VII, IX, X, XI, XII, Plasminogen, 2-Antiplasmin and vWF:Ag. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit. May also be used as negative control for Lupus Anticoagulant.
BIOPHENâ„¢ Plasma Calibrator
In EU and Canada: For In Vitro Diagnostic Use. Abnormal human plasma for the quality control of assays for Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Prothrombin, Factors VII+X, Factors V, VII, IX, X, XI, XII, Plasminogen, 2-Antiplasmin, PT/INR/%, aPTT, and vWF:Ag. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit. May also be used as negative control for Lupus Anticoagulant.
BIOPHENâ„¢ Plasma Calibrator
510(k) Cleared for In Vitro Diagnostic Use. Abnormal human plasma for the quality control of assays for Protein C, Protein S, Antithrombin, PT, aPTT, Fibrinogen, Factor VIII:C, Prothrombin, Factors VII+X, Factors V, VII, IX, X, XI, XII, Plasminogen, 2-Antiplasmin, PT/INR/%, aPTT, and vWF:Ag. The exact concentration and the acceptance ranges for each factor are indicated on the flyer provided with each kit. May also be used as negative control for Lupus Anticoagulant.
BIOPHENâ„¢ Heparin Calibrator
In EU: This Product is CE Marked. Health Canada Licensed. Range of calibration plasmas supplemented with Low Molecular Weight Heparin (LMWH) (4 sets at 5 different heparin levels from 0 to 1.60 IU/mL) for the assay of heparin (UFH or LMWH) using chromogenic anti-Xa assays.
BIOPHENâ„¢ Heparin Calibrator
In US: 510(k) Cleared for In Vitro Diagnostic Use. Range of calibration plasmas supplemented with Low Molecular Weight Heparin (LMWH) (4 sets at 5 different heparin levels from 0 to 1.60 IU/mL) for the assay of heparin (UFH or LMWH) using chromogenic anti-Xa assays.
BIOPHENâ„¢ FIXa (ACT. FIX)
For Research Use Only. Not for Use in Diagnostic Procedures. Chromogenic assay for measuring Factor IXa (Activated Factor IX) activity in human citrated plasma (or in Factor IX concentrates), using a chromogenic method, manual or automated. For testing Factor IXa in purified Factor IX or concentrates, a pre-dilution in Factor IX deficient plasma or in R4 buffer is recommended.
BIOPHENâ„¢ Factor IX (6 mL)
In US: For Research Use Only. Not for Use in Diagnostic Procedures. Chromogenic assay for the measurement of Factor IX activity in human citrated plasma or Factor IX concentrates. Automated or Manual Method. Calibrator plasma and controls (at two levels) are available. This assay offers two working ranges for Factor IX (Low: 0 to 20% and High: 5 to 200%). For purified Factor IX or concentrates, a pre-dilution in Factor IX deficient plasma is recommended. Replaces product code A221805.
