Diagnostica Stago, Inc.

Web: http://www.stago-us.com
Address: Five Century Drive, Parsippany, New Jersey 07054, USA
Phone: +1-(973)-631-1200 | Fax: +1-(973)-631-1618 | Map/Directions >>

Profile: Diagnostica Stago, Inc. offers a complete system of hemostasis instrumentation & optimized reagent kits for research, as well as for routine analysis. Our viscosity based detection system reduces the interference from lipemia, icterus or hemolysis-maximizes accuracy and precision. Our STA Compact® CT is a completely automated, benchtop hemostasis analyzer capable of performing clotting assays in random access mode. Our Start®4 is a small, semi-automated system that is perfect for the low volume workload laboratory.

The company was founded in 1985, has revenues of USD 50-100 Million, has ~200 employees and is ISO 9001, CE certified.

FDA Registration Number: 9610666
US Agent: Donald Kraft / Diagnostica Stago, Inc
Phone: +1-(973)-631-1200  Fax: +1-(973)-775-8082  E-Mail:

43 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.
• Antithrombin III Quantitation Test (FDA Code: JBQ / 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).
• Automated Coagulation Analyzer (FDA Code: GKP / 864.5400)
A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.
• Automated Coagulation Instrument (FDA Code: GKP / 864.5400)
• Blood Clot Coagulation Analyzer (FDA Code: GKP / 864.5400)
• Bothrops Atrox Reagent (FDA Code: JCO / 864.8100)
A Bothrops atrox reagent is a device made from snake venom and used to determine blood fibrinogen levels to aid in the evaluation of disseminated intravascular coagulation (nonlocalized clotting in the blood vessels) in patients receiving heparin therapy (the administration of the anticoagulant heparin in the treatment of thrombosis) or as an aid in the classification of dysfibrinogenemia (presence in the plasma of functionally defective fibrinogen).
• Buffer Solution
• Chromogenic Substrates
• Coagulation Analyzer with Timer (FDA Code: GKP / 864.5400)
• Coagulation Analyzers (FDA Code: GKP / 864.5400)
• 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 Factors
• Coagulation Inhibitor
• Coagulation Test Kits
• Control Thromboplastin Reagent (FDA Code: GGO / 864.7925)
• Creatine Conversion To Creatinine (FDA Code: JLA / 862.1210)
A creatine test system is a device intended to measure creatine (a substance synthesized in the liver and pancreas and found in biological fluids) in plasma, serum, and urine. Measurements of creatine are used in the diagnosis and treatment of muscle diseases and endocrine disorders including hyperthyroidism.
• Enzyme Immunoassay Test
• Fibrin Monomer Paracoagulation Test (FDA Code: JBN / 864.7300)
A fibrin monomer paracoagulation test is a device used to detect fibrin monomer in the diagnosis of disseminated intravascular coagulation (nonlocalized clotting within a blood vessel) or in the differential diagnosis between disseminated intravascular coagulation and primary fibrinolysis (dissolution of the fibrin in a blood clot).
• 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 and Fibrin Split Products (FDA Code: DAP / 864.7320)
• 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).
• Fully Automated Random Access Coagulation Analyzer
• Hemostasis Products
• Heparin Assay (FDA Code: KFF / 864.7525)
A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).
• Laboratory Coagulation Analyzers
• Multi Analyte Mixture - Calibrator (FDA Code: JIX / 862.1150)
A calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. (See also 862.2 in this part.)
• Multipurpose System for Invitro Coagulation Studies (FDA Code: JPA / 864.5425)
• Neurology Instruments
• Normal Control Plasma (FDA Code: GIZ / 864.5425)
• Partial Thromboplastin Test Time (FDA Code: GGW / 864.7925)
• Plasma Coagulation Control (FDA Code: GGN / 864.5425)
• Plasminogen (FDA Code: DDX / 866.5715)
A plasminogen immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the plasminogen (an inactive substance from which plasmin, a blood-clotting factor, is formed) in serum, other body fluids, and tissues. Measurement of plasminogen levels may aid in the diagnosis of fibrinolytic (blood-clotting) disorders.
• Platelet Aggregometer (FDA Code: JBX / 864.6675)
A platelet aggregometer is a device, used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet rich plasma.
• Platelet Factor 4 Radioimmunoassay (FDA Code: LCO / 864.7695)
A platelet factor 4 radioimmunoassay is a device used to measure the level of platelet factor 4, a protein released during platelet activation by radioimmunoassay. This device measures platelet activiation, which may indicate a coagulation disorder, such as myocardial infarction or coronary artery disease.
• POC Coagulation Analyzers (PT and INR)
• Point-of-care (POC) Coagulation Analyzers
• 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)
• Reagent & Control Partial Thromboplastin Time (FDA Code: GIT / 864.7925)
• 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.
• 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.
• Viscosity Based Detection System

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