R2 Diagnostics Inc

Address: 1801 Commerce Drive, South Bend, Indiana 46628, USA
Phone: +1-(574)-288-4377 | Fax: +1-(574)-288-2272 | Map/Directions >>

Profile: r2 Diagnostics Inc produces re-agents for routine coagulation testing with a major emphasis on the detection of thrombophilia. We are an ISO 13485:2003 certified company. Our product Phosphoplastin RL is intended for use in a one-stage prothrombin time test on citrated human plasma.

FDA Registration Number: 1835316

17 Products/Services (Click for related suppliers)  
• Abnormal Plasma Control (FDA Code: GGC / 864.5425)
A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.
• Activated Partial Thromboplastin (FDA Code: GFO / 864.7925)
A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.
• Coagulation Factor Deficient Plasma (FDA Code: GJT / 864.7290)
A factor deficiency test is a device used to diagnose specific coagulation defects, to monitor certain types of therapy, to detect coagulation inhibitors, and to detect a carrier state (a person carrying both a recessive gene for a coagulation factor deficiency such as hemophilia and the corresponding normal gene).
• Coagulation Test Kits
• Fibrin Split Products (FDA Code: GHH / 864.7320)
A fibrinogen/fibrin degradation products assay is a device used to detect and measure fibrinogen degradation products and fibrin degradation products (protein fragments produced by the enzymatic action of plasmin on fibrinogen and fibrin) as an aid in detecting the presence and degree of intravascular coagulation and fibrinolysis (the dissolution of the fibrin in a blood clot) and in monitoring therapy for disseminated intravascular coagulation (nonlocalized clotting in the blood vessels).
• Fibrinogen Determination System Test (FDA Code: KQJ / 864.7340)
A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).
• Fibrinogen Test (FDA Code: GIS / 864.7340)
• General Purpose Reagent (FDA Code: LDT)
• Human/Horse/Rabbit Coagulase Plasma (FDA Code: JTL / 866.2160)
Coagulase plasma is a device that consists of freeze-dried animal or human plasma that is intended for medical purposes to perform coagulase tests primarily on staphylococcal bacteria. When reconstituted, the fluid plasma is clotted by the action of the enzyme coagulase which is produced by pathogenic staphylococci. Test results are used primarily as an aid in the diagnosis of disease caused by pathogenic bacteria belonging to the genusStaphylococcus and provide epidemiological information on disease caused by these microorganisms.
• Normal Control Plasma (FDA Code: GIZ / 864.5425)
• Partial Thromboplastin Test Time (FDA Code: GGW / 864.7925)
• Prothrombin Time Test (FDA Code: GJS / 864.7750)
A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).
• Qualitative and Quantitative Factor Deficiency Test (FDA Code: GGP / 864.7290)
• Russel Viper Venom Reagent (FDA Code: GIR / 864.8950)
Russell viper venom reagent is a device used to determine the cause of an increase in the prothrombin time.
• Systemic Lupus Erythematosus Test (FDA Code: DHC / 866.5820)
A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).
• Thrombin Time Test (FDA Code: GJA / 864.7875)
A thrombin time test is a device used to measure fibrinogen concentration and detect fibrin or fibrinogen split products for the evaluation of bleeding disorders.
• Two Stage Clotting Time Assay for Antithrombin III (FDA Code: JPE / 864.7060)
An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).

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