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

51 to 100 of 131 Products/Services (Click for related suppliers)  Page: 1 [2] 3

• 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 Control Plasma (FDA Code: GIL / 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)

• Fluorescent Antibody for FTA-ABS Test Antiserum (FDA Code: GMX / 866.3830)

• Free Thyroxine Radioimmunoassay (FDA Code: CEC / 862.1695) A free thyroxine test system is a device intended to measure free (not protein bound) thyroxine (thyroid hormone) in serum or plasma. Levels of free thyroxine in plasma are thought to reflect the amount of thyroxine hormone available to the cells and may therefore determine the clinical metabolic status of thyroxine. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

• FTA-ABS Test Anti-Human Globulin (FDA Code: GMS / 866.3830)

• FTA-ABS Test Reactive and Non-Specific Control Serum (FDA Code: GMR / 866.3830)

• FTA-ABS Test Sorbent (FDA Code: GMW / 866.3830)

• Glycosylated Hemoglobin Assay Test (FDA Code: LCP / 864.7470) A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

• HDL Precipitation Method (FDA Code: LBR / 862.1475) A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

• 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).

• Herpes Simplex Virus Enzyme Linked Immunoabsorbent Assay (FDA Code: LGC / 866.3305)

• HIV Detection Test (FDA Code: MZF)

• HSV-1 Herpes Simplex Virus Enzyme-Linked Immunosorbent Assay (FDA Code: MXJ / 866.3305)

• HSV-2 Herpes Simplex Virus Enzyme-Linked Immunosorbent Assay (FDA Code: MYF / 866.3305)

• IFA Antibody Antigen Respiratory Syncytial Virus (FDA Code: LKT / 866.3480) Respiratory syncytial virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to respiratory syncytial virus in serum. Additionally, some of these reagents consist of respiratory syncytial virus antisera conjugated with a fluorescent dye (immunofluorescent reagents) and used to identify respiratory syncytial viruses from clinical specimens or from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of respiratory syncytial virus infections and provides epidemiological information on diseases caused by these viruses. Respiratory syncytial viruses cause a number of respiratory tract infections, including the common cold, pharyngitis, and infantile bronchopneumonia.

• Indirect Fluorescent Antibody Test System Anti-Cardiac For Export Only - Antigen (FDA Code: NUK)

• Indirect Fluorescent Antibody Test System for Anti-Skeletal For Export Only - Antigen (FDA Code: NUL)

• Indirect Immunofluorescent Antimitochondrial Antibody Test (FDA Code: DBM / 866.5090) An antimitochondrial antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the antimitochondrial antibodies in human serum. The measurements aid in the diagnosis of diseases that produce a spectrum of autoantibodies (antibodies produced against the body's own tissue), such as primary biliary cirrhosis (degeneration of liver tissue) and chronic active hepatitis (inflammation of the liver).

• Infectious Disease Test Kits

• Influenza Virus (A, B, C) Antisera (FDA Code: GNW / 866.3330) Influenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to influenza in serum. The identification aids in the diagnosis of influenza (flu) and provides epidemiological information on influenza. Influenza is an acute respiratory tract disease, which is often epidemic.

• Influenza Virus CF Antigen (FDA Code: GNX / 866.3330)

• Lactic Acid Enzymatic Method (FDA Code: KHP / 862.1450) A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

• LDL & VLDL Precipitation Method (FDA Code: LBR / 862.1475)

• LDL & VLDL Precipitation, Cholesterol Via Esterase-Oxidase (FDA Code: LBS / 862.1475)

• Legionella Direct & Indirect Fluorescent Antibody Regents (FDA Code: LHL / 866.3300)

• Legionella Spp. ELISA (FDA Code: MJH / 866.3300)

• Lipase Photometric Enzymatic Lipase-Esterase Test (FDA Code: CHI / 862.1465) A lipase test system is a device intended to measure the activity of the enzymes lipase in serum. Lipase measurements are used in diagnosis and treatment of diseases of the pancreas such as acute pancreatitis and obstruction of the pancreatic duct.

• Lipoprotein Low-Density Test System (FDA Code: MRR / 862.1475)

• Lipoproteins Electrophoretic Separation Test (FDA Code: JHO / 862.1475)

• Low Density Lipoprotein (FDA Code: DFC / 866.5600) A low-density lipoprotein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the low-density lipoprotein in serum and other body fluids. Measurement of low-density lipoprotein in serum may aid in the diagnosis of disorders of lipid (fat) metabolism and help to identify young persons at risk from cardiovascular diseases.

• Lyme Disease (Borrelia) Test Kits

• Lyme Disease Test

• Microbiology Diagnostic Device (FDA Code: LIB / 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.

• Microscope Slide Coverslip (FDA Code: KES / 864.3010) Tissue processing equipment consists of devices used to prepare human tissue specimens for diagnostic histological examination by processing specimens through the various stages of decalcifying, infiltrating, sectioning, and mounting on microscope slides.

• Mounting Media (FDA Code: LEB / 864.4010)

• Multipurpose System for Invitro Coagulation Studies (FDA Code: JPA / 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.

• Mumps Virus Enzyme Linked Immunoabsorbent Assay (FDA Code: LJY / 866.3380) Mumps virus serological reagents consist of antigens and antisera used in serological tests to identify antibodies to mumps virus in serum. Additionally, some of these reagents consist of antisera conjugated with a fluorescent dye (immunofluorescent reagents) used in serological tests to identify mumps viruses from tissue culture isolates derived from clinical specimens. The identification aids in the diagnosis of mumps and provides epidemiological information on mumps. Mumps is an acute contagious disease, particularly in children, characterized by an enlargement of one or both of the parotid glands (glands situated near the ear), although other organs may also be involved.

• Mycoplasma Spp Enzyme Linked Immunoabsorbent Assay (FDA Code: LJZ / 866.3375)

• N. Gonorrhoeae (All Groups) Fluorescent (Direct Test) Antiserum (FDA Code: GTH / 866.3390)

• Non-Propagating Transport Culture Media (FDA Code: JSM / 866.2390) A transport culture medium is a device that consists of a semisolid, usually non-nutrient, medium that maintains the viability of suspected pathogens contained in patient specimens while in transit from the specimen collection area to the laboratory. The device aids in the diagnosis of disease caused by pathogenic microorganisms and also provides epidemiological information on these diseases.

• Normal Control Plasma (FDA Code: GIZ / 864.5425)

• Oxalate Test System (FDA Code: LPW / 862.1542) An oxalate test system is a device intended to measure the concentration of oxalate in urine. Measurements of oxalate are used to aid in the diagnosis or treatment of urinary stones or certain other metabolic disorders.

• Parainfluenza Virus 1-4 CF Antisera (FDA Code: GQT / 866.3400) Parainfluenza virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to parainfluenza virus in serum. The identification aids in the diagnosis of parainfluenza virus infections and provides epidemiological information on diseases caused by these viruses. Parainfluenza viruses cause a variety of respiratory illnesses ranging from the common cold to pneumonia.

• Parainfluenza Virus CF Antigen (FDA Code: GQS / 866.3400)

• Partial Thromboplastin Test Time (FDA Code: GGW / 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.

• 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.

• Primary Calibrator (FDA Code: JIS / 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.)