American Diagnostica Inc

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Web: http://www.americandiagnostica.com
E-Mail:
Address: 500 West Ave, PO Box 110215, Stamford, Connecticut 06911, USA
Phone: +1-(203)-602-7777 | Fax: +1-(203)-602-2221 | Map/Directions >>
 
 

Profile: American Diagnostica Inc markets, supplies and manufactures novel medical diagnostic products. We focus on diagnosis and research of disorders involving angiogenesis, blood coagulation, fibrinolysis, hemostasis, metastasis & thrombosis. Our product line includes special coagulation assays, D-dimer assays, cardiac markers and coagulation system proteins. We supply products to hospitals, medical testing laboratories, university research facilities and pharmaceutical companies. We are accredited with ISO 9000 certification.

The company was founded in 1982, has revenues of USD 5-10 Million, has ~40 employees.

FDA Registration Number: 1220602

34 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.
• Analyte Specific Reagents, Asr Reagents (FDA Code: MVU / 864.4020)
Analyte specific reagents (ASR's) are antibodies, both polyclonal and monoclonal, specific receptor proteins, ligands, nucleic acid sequences, and similar reagents which, through specific binding or chemical reaction with substances in a specimen, are intended for use in a diagnostic application for identification and quantification of an individual chemical substance or ligand in biological specimens. ASR's that otherwise fall within this definition are not within the scope of subpart E of this part when they are sold to:
• Anti-acetylcholine Receptor Alpha Monoclonal Antibody
• 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).
• B2 - Glycoprotein I Antibodies Test System (FDA Code: MSV / 866.5660)
A multiple autoantibodies immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoantibodies (antibodies produced against the body's own tissues) in serum and other body fluids. Measurement of multiple autoantibodies aids in the diagnosis of autoimmune disorders (disease produced when the body's own tissues are injured by autoantibodies).
• Blood Collection Systems (FDA Code: JKA / 862.1675)
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
• Breast Cancer Detection Kit Test
• C-Reactive Protein (CRP), FITC Conjugate (FDA Code: DCK / 866.5270)
A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.
• Cancer Detection Test
• Cancer Test Kits
• 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
• Control Antiserum/Antigen
• Enzyme Immunoassay
• Enzyme Immunoassay Test
• 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)
• Flow Cytometry
• Flow Cytometry Test Kits
• Hematology Kits
• 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).
• Immunological Anticardiolipin Test System (FDA Code: MID / 866.5660)
• Monoclonal Antibody Test
• Normal Control Plasma (FDA Code: GIZ / 864.5425)
• Phlebotomy Needles & Tourniquets
• Plasma Coagulation Control (FDA Code: GGN / 864.5425)
• 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).
• Publications
• Publications Service
• 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.
• Tourniquets
• Tumor Antigen Immunological Test System (FDA Code: MOI / 866.6010)
A tumor-associated antigen immunological test system is a device that consists of reagents used to qualitatively or quantitatively measure, by immunochemical techniques, tumor-associated antigens in serum, plasma, urine, or other body fluids. This device is intended as an aid in monitoring patients for disease progress or response to therapy or for the detection of recurrent or residual disease.
• Whole Blood Hemoglobin Determination Test (FDA Code: KHG / 864.7500)
A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.

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