PRODUCT CATALOG

PRODUCT CATALOG
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PRODUCT CATALOG

Product catalog summary
Product Overview
HYPHEN BioMed specializes in in vitro diagnostic reagents for thrombosis, hemostasis, fibrinolysis, and autoimmunity. They offer a wide range of certified hemostasis reagents suitable for various systems.
Product Offerings
  • HEMOCLOT™: Clotting assays for IVD and research.
  • BIOPHEN™: Chromogenic assays traceable to international standards.
  • ZYMUTEST™: Enzyme immunoassays for thrombotic diseases.
  • LIAPHEN™: Turbidimetric latex immunoassays.
  • ZYMUPHEN™: Bio-immunoassays for rare protein activities.
  • Aggregometry: Platelet functional assays.
Customized Research Products
HYPHEN BioMed offers customized reagents and materials for tailored research solutions.
Support for External Quality Assessment (EQA)
They provide lyophilized plasma materials for EQA organizations.
Regulatory Status
  • RUO: For research use only.
  • CE-IVD: CE marked for in vitro diagnostic use.
  • 510(k): US marked for IVD use.
Quality System
Certified for ISO 13485:2016 and MDSAP, transitioning to EU regulation 2017/746.
Systems Compatibility
Compatible with major coagulation analyzers like Sysmex and Werfen ACL TOP® Family.
Key Assays and Tests
  • Prothrombin Time (PT): For monitoring anticoagulant therapy.
  • Activated Partial Thromboplastin Time (aPTT): Screens for coagulation deficiencies.
  • Fibrinogen: Measures fibrinogen concentration.
  • Thrombin Time (TT): Assesses fibrinogen abnormalities.
Calibrators and Controls
Provides a range of calibrators and controls for accurate test results.
Diagnostic and Research Products
Includes assays for factors like FVII, FX, FXIII, FII, FV, AT, PC, and PS, with detailed specifications and applications.
Protein S Assays
Describes assays for different types of protein S deficiencies using various methods.
Lupus Anticoagulant Testing
Assays for confirming lupus anticoagulant presence.
Autoantibody Assays
Assays for measuring autoantibodies related to autoimmune disorders.
Coagulation Factor Assays
Assays for activated coagulation factors essential for diagnosing bleeding disorders.
Research Applications
Several assays designated for research use only.
Anticoagulant Overview
Details on anticoagulants and associated risks, with emphasis on DOACs.
Assay Portfolio for Anticoagulants
Includes assays for monitoring anticoagulant therapy and detecting HIT.
Calibrators and Controls
Comprehensive list for ensuring assay accuracy.
Research Products
Includes purified proteins and enzymes for research use.
Conclusion
Serves as a technical guide for laboratories conducting coagulation and autoantibody testing.
See more

Catalog excerpts

PRODUCT CATALOG-1

PRODUCT CATALOG Last update March 2022

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PRODUCT CATALOG-3

As a dedicated company to in vitro diagnostic reagents, HYPHEN BioMed offers to clinical and specialized laboratories, pharmaceutical PRODUCTS LIST CODIFICATION Reference Codification Product range industry, or medical research, a wide range of in vitro diagnostic and research reagents for the exploration of thrombosis, hemostasis, Auxiliary Reagents Bovine Enzymes Bovine Proteins Deficient Plasma Human Enzymes Purified Proteins Recombinant Proteins Recombinant Human proteins Standards & Controls HYPHEN BIOMED OFFER Based on advanced techniques, the company offers certified hemostasis reagents...

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PRODUCT CATALOG-4

GLOBAL & ROUTINE TESTS A SUPPORT FOR EQA (EXTERNAL QUALITY ASSESSMENT) PRIMARY HEMOSTASIS With the company’s recognized experience, its offer for a full range of calibrators and controls, and its high-capacity manufacturing equipment, HYPHEN BioMed can provide you with lyophilized plasma materials for external quality assessment (EQA) organizations. HYPHEN BioMed can meet your expectations with normal or pathological samples for routine hemostasis assays, or anticoagulation monitoring (e.g. heparins and heparin-like spiked samples, direct anti-Xa or anti-IIa inhibitors spiked in plasma, …). All...

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PRODUCT CATALOG-5

AUXILIARY REAGENTS CALIBRATORS & CONTROLS GLOBAL & ROUTINE TESTS FIBRINOLYSIS MONITORING ANTICOAGULANT BLEEDING DISORDERS PRIMARY HEMOSTASIS GLOBAL & ROUTINE TESTS

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PRODUCT CATALOG-6

GLOBAL & ROUTINE TESTS with hemostasis disorders. PRIMARY HEMOSTASIS Coagulation screening tests are necessary to explore patients AUXILIARY REAGENTS CALIBRATORS & CONTROLS MONITORING ANTICOAGULANT the dysfunction of the coagulation cascade exposing patients to bleeding. BLEEDING DISORDERS The global measurement of intrinsic and extrinsic pathways help to clearly highlight Coagulation pathways

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PRODUCT CATALOG-7

• EASYPLASMA™ Calibrator CK584L LRT CE-IVD Liquid and CK586K Ready to use CK586L CONTROLS Product Name • BIOPHEN™ Normal Control Plasma • BIOPHEN™ Abnormal Control Plasma • EASYPLASMA™ Control Set Product Name GLOBAL & ROUTINE TESTS CONTROLS Ref. Product Name • BIOPHEN™ Normal 223201 Control Plasma • BIOPHEN™ Abnormal 223301 Control Plasma • EASYPLASMA™ 225601 Control Set Weak • LA Control Plasma High • IOPHEN™ Normal B Control Plasma • IOPHEN™ Abnormal B Control Plasma • EASYPLASMA™ Control Set Elevated fibrinogen concentrations are observed in inflammation and have also been considered as a...

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PRODUCT CATALOG-8

• BIOPHEN™ Normal 223201 Control Plasma • BIOPHEN™ Abnormal 223301 Control Plasma BIOPHEN™ Plasma Calibrator ZYMUTEST™ Fibrinogen C2: 2 x 1 mL Five certified plasmas for PT/INR and CE-IVD PT% calibration and/or for SC084K C3: 2 x 1 mL verification of local ISI test system C4: 2 x 1 mL C5: 2 x 1 mL Measurement of human Fibrinogen in plasma, or in any fluid where Fibrinogen can be present, with an Elisa method. COMPLETE SOLUTION Product Name RS Ref. • ZYMUTEST™ RUO Fibrinogen • HEMOCLOT™ CK011K Thrombin CE-IVD Time (T.T.) CK011L Product Name • EASYPLASMA™ Calibrator Product Name Quality control...

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PRODUCT CATALOG-9

AUXILIARY REAGENTS CALIBRATORS & CONTROLS PRIMARY HEMOSTASIS FIBRINOLYSIS MONITORING ANTICOAGULANT BLEEDING DISORDERS PRIMARY HEMOSTASIS GLOBAL & ROUTINE TESTS

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PRODUCT CATALOG-10

GLOBAL & ROUTINE TESTS In the event of a vascular breach, blood platelets contribute to maintain the vessels’ PRIMARY HEMOSTASIS PLATELETS’ ROLE Exploring platelet functions is therefore highly useful for diagnosis of platelets anomalies and monitoring anti-aggregant treatments. BLEEDING DISORDERS integrity by ensuring primary hemostasis, before being involved for coagulation. Blood flow Vasospasm / Rolling Blood flow Blood flow AUXILIARY REAGENTS Platelet released products Vasospasm / Rolling Vasospasm / Rolling Adhesion Activation Platelet released products Activation Platelets plug Platelets...

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PRODUCT CATALOG-11

Sysmex analyzers CS Series CN series except CS 1600 OTHER RELATED ASSAYS Screening for thrombocytopathy, whether systemic or acquired. Biological monitoring of anti-platelet therapy. AVAILABLE ON Product Name • Arachidonic Acid Lyophilized Platelets Platelets for Ristocetin cofactor activity assay (vWF:RCo). Sysmex analyzers CS Series except CS 1600 REAGENT Product Name RS • Lyophilized Screening for thrombocytopathy, whether systemic or acquired. Biological monitoring of anti-platelet therapy. Determination of von Willebrand Factor Antigen (vWF: Ag), in human citrated plasma with a Latex turbidimetric...

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PRODUCT CATALOG-12

GLOBAL & ROUTINE TESTS Research vWF Deficient Plasma PRIMARY HEMOSTASIS For any study or research protocol where a source of human vWF deficient plasma is required. This plasma is also FVIII deficient. REAGENT RS Product Name ZYMUTEST™ PF4 Measurement of human Platelet Factor 4 (PF4) by Elisa in platelet depleted plasma, or in any fluid where PF4 must be measured. COMPLETE SOLUTION RS AUXILIARY REAGENTS BLEEDING DISORDERS CALIBRATORS & CONTROLS MONITORING ANTICOAGULANT Product Name

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PRODUCT CATALOG-13

Factor VIII:C Deficient Plasma GLOBAL & ROUTINE TESTS Factor X Factor XIII Elisa Assay on-demand on-demand Chromogenic Assay Clotting Assay Common Pathway BLEEDING DISORDERS Extrinsic Pathway Factor Factor VII VII-X MONITORING ANTICOAGULANT Intrinsic Pathway PRIMARY HEMOSTASIS Factors assay portfolio: AUXILIARY REAGENTS CALIBRATORS & CONTROLS * Inhibitor assay

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PRODUCT CATALOG-14

GLOBAL & ROUTINE TESTS A Factor VIII (FVIII) (or antihemophilic Factor A) deficiency or dysfunction leads to hemophilia A, which is an hereditary or congenital hemorrhagic disease. Elevated concentrations of FVIII are observed in inflammatory or hepatic diseases and may be suggestive of an increased risk of venous thrombosis. The FVIII concentration is increased during pregnancy. A Factor IX (FIX) (or antihemophilic Factor B) deficiency or dysfunction leads to the hemophilia B disease, an hereditary or congenital coagulation disorder. FIX levels are reduced in patients receiving anti-vitamin...

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