Profile: Mardx Diagnostics, Inc. is engaged in developing, manufacturing, and marketing of diagnostic products. We offer western blot, IFA, EIA,and ENA IgG marstripe immunostride tests for 6 extractable nuclear antigens such as SSA, SSB, SLC-70, JO-1, RNP, & SM. Our western blot is used to test and confirm the primary diagnosis of certain infectious diseases, including lyme disease.

The company has revenues of USD 5-10 Million. (SEC Filings)

FDA Registration Number: 2245544

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• 2 Herpesvirus Hominis 1 CF Antigen (FDA Code: GQN / 866.3305)

• 2 Herpesvirus Hominis 1 Cf Antisera (FDA Code: GQO / 866.3305)

• 2 Herpesvirus Hominis 1 Fluorescent Antisera (FDA Code: GQL / 866.3305)

• Abnormal Hemoglobin Quantitation Test (FDA Code: GKA / 864.7415) An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.

• 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.

• Adenovirus 1-33 CF Antigen (FDA Code: GOD / 866.3020) Adenovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to adenovirus in serum. Additionally, some of these reagents consist of adenovirus antisera conjugated with a fluorescent dye and are used to identify adenoviruses directly from clinical specimens. The identification aids in the diagnosis of disease caused by adenoviruses and provides epidemiological information on these diseases. Adenovirus infections may cause pharyngitis (inflammation of the throat), acute respiratory diseases, and certain external diseases of the eye (e.g., conjunctivitis).

• Adenovirus 1-33 CF Antisera (FDA Code: GOA / 866.3020)

• 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:

• Angiotensin Converting Enzyme Radioassay (FDA Code: KQN / 862.1090) An angiotensin converting enzyme (A.C.E.) test system is a device intended to measure the activity of angiotensin converting enzyme in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of diseases such as sarcoidosis, a disease characterized by the formation of nodules in the lungs, bones, and skin, and Gaucher's disease, a hereditary disorder affecting the spleen.

• Anti-Ribosomal P Antibodies (FDA Code: MQA / 866.5100) An antinuclear antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum, other body fluids, and tissues that react with cellular nuclear constituents (molecules present in the nucleus of a cell, such as ribonucleic acid, deoxyribonucleic acid, or nuclear proteins). The measurements aid in the diagnosis of systemic lupus erythematosus (a multisystem autoimmune disease in which antibodies attack the victim's own tissues), hepatitis (a liver disease), rheumatoid arthritis, Sjogren's syndrome (arthritis with inflammation of the eye, eyelid, and salivary glands), and systemic sclerosis (chronic hardening and shrinking of many body tissues).

• Antibodies to Glomerular Basement Membrane (gbm) Measure Devices (FDA Code: MVJ / 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).

• Antigen And Control Extractable Antinuclear Antibody (FDA Code: LLL / 866.5100)

• Antineutrophil Cytoplasmic Antibodies (ANCA) Test System (FDA Code: MOB / 866.5660)

• Antithrombin III Control (FDA Code: DDQ / 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).

• Antithrombin III Quantitation Test (FDA Code: JBQ / 864.7060)

• Assayed and Unassayed Single (Specified) Analyte Controls (FDA Code: JJX / 862.1660) A quality control material (assayed and unassayed) for clinical chemistry is a device intended for medical purposes for use in a test system to estimate test precision and to detect systematic analytical deviations that may arise from reagent or analytical instrument variation. A quality control material (assayed and unassayed) may be used for proficiency testing in interlaboratory surveys. This generic type of device includes controls (assayed and unassayed) for blood gases, electrolytes, enzymes, multianalytes (all kinds), single (specified) analytes, or urinalysis controls.

• Automated Antimicrobial Susceptibility Test System (FDA Code: LON / 866.1645) A fully automated short-term incubation cycle antimicrobial susceptibility system is a device that incorporates concentrations of antimicrobial agents into a system for the purpose of determining in vitro susceptibility of bacterial pathogens isolated from clinical specimens. Test results obtained from short-term (less than 16 hours) incubation are used to determine the antimicrobial agent of choice to treat bacterial diseases.

• 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)

• B.Pertussis Antigen (FDA Code: GOX / 866.3065)

• Bile Acids Cholyglycine Radioimmunoassay (FDA Code: KWW / 862.1177) A cholylglycine test system is a device intended to measure the bile acid cholylglycine in serum. Measurements obtained by this device are used in the diagnosis and treatment of liver disorders, such as cirrhosis or obstructive liver disease.

• Blood Clot Coagulation Analyzer (FDA Code: GKP / 864.5400)

• Borrelia Serological Reagent (FDA Code: LSR / 866.3830)

• 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).

• Campylobacter Pylori (FDA Code: LYR / 866.3110)

• Chlamydia Group Enzyme Linked Immunoabsorbent Assay (FDA Code: LJC / 866.3120) Chlamydia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to chlamydia in serum. Additionally, some of these reagents consist of chlamydia antisera conjugated with a fluorescent dye used to identify chlamydia directly from clinical specimens or cultured isolates derived from clinical specimens. The identification aids in the diagnosis of disease caused by bacteria belonging to the genusChlamydia and provides epidemiological information on these diseases. Chlamydia are the causative agents of psittacosis (a form of pneumonia), lymphogranuloma venereum (a venereal disease), and trachoma (a chronic disease of the eye and eyelid).

• Chlamydia Trachomatis Fluorescent Antiserum (FDA Code: LJP / 866.3120)

• Clostridium Difficile Antigen (FDA Code: MCB / 866.2660) A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.

• 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).

• Control Antigen Antinuclear Antibody (FDA Code: LKJ / 866.5100)

• Control Thromboplastin Reagent (FDA Code: GGO / 864.7925)

• Culture Media Supplements (FDA Code: JSK / 866.2450) A supplement for culture media is a device, such as a vitamin or sugar mixture, that is added to a solid or liquid basal culture medium to produce a desired formulation and that is intended for medical purposes to enhance the growth of fastidious microorganisms (those having complex nutritional requirements). This device aids in the diagnosis of diseases caused by pathogenic microorganisms.

• Cultured Animal and Human Cells (FDA Code: KIR / 864.2280) Cultured animal and human cells are in vitro cultivated cell lines from the tissue of humans or other animals which are used in various diagnostic procedures, particularly diagnostic virology and cytogenetic studies.

• Cytomegalovirus CF Antigen (FDA Code: GQH / 866.3175) Cytomegalovirus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to cytomegalovirus in serum. The identification aids in the diagnosis of diseases caused by cytomegaloviruses (principally cytomegalic inclusion disease) and provides epidemiological information on these diseases. Cytomegalic inclusion disease is a generalized infection of infants and is caused by intrauterine or early postnatal infection with the virus. The disease may cause severe congenital abnormalities, such as microcephaly (abnormal smallness of the head), motor disability, and mental retardation. Cytomegalovirus infection has also been associated with acquired hemolytic anemia, acute and chronic hepatitis, and an infectious mononucleosis-like syndrome.

• Cytomegalovirus CF Antiserum Test (FDA Code: GQI / 866.3175)

• Cytomegalovirus Conjugated Fluorescent Antisera Test (FDA Code: LIN / 866.3175)

• Cytomegalovirus Enzyme Linked Immunoabsorbent Assay (FDA Code: LFZ / 866.3175)

• Endomysial Autoantibodies (FDA Code: MVM / 866.5660)

• Enriched Culture Media (FDA Code: KZI / 866.2330) An enriched culture medium is a device that consists primarily of liquid or solid biological materials intended for medical purposes to cultivate and identify fastidious microorganisms (those having complex nutritional requirements). The device consists of a relatively simple basal medium enriched by the addition of such nutritional components as blood, blood serum, vitamins, and extracts of plant or animal tissues. The device is used in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

• Entamoeba Histolytica Antigen (FDA Code: KHW / 866.3220)

• Enzyme Labeled Anti-DNA Antibody (FDA Code: LRM / 866.5100)

• Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 866.5100)

• Epstein-Barr Virus (FDA Code: LSE / 866.3235) Epstein-Barr virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to Epstein-Barr virus in serum. The identification aids in the diagnosis of Epstein-Barr virus infections and provides epidemiological information on diseases caused by these viruses. Epstein-Barr viruses are thought to cause infectious mononucleosis and have been associated with Burkitt's lymphoma (a tumor of the jaw in African children and young adults) and postnasal carcinoma (cancer).

• Epstein-Barr Virus CF Antiserum (FDA Code: GNP / 866.3235)

• Epstein-Barr Virus Nuclear Antigen Test (FDA Code: LLM / 866.3235)

• Erythrocytic Screening Glucose-6-Phosphate Dehydrogenase (FDA Code: JBF / 864.7360) An erythrocytic glucose-6-phosphate dehydrogenase assay is a device used to measure the activity of the enzyme glucose-6-phosphate dehydrogenase or of glucose-6-phosphate dehydrogenase isoenzymes. The results of this assay are used in the diagnosis and treatment of nonspherocytic congenital hemolytic anemia or drug-induced hemolytic anemia associated with a glucose-6-phosphate dehydrogenase deficiency. This generic device includes assays based on fluorescence, electrophoresis, methemoglobin reduction, catalase inhibition, and ultraviolet kinetics.

• Erythrocytic Spot Glucose-6-phosphate Dehydrogenase (FDA Code: JBG / 864.7360)