Profile: Diagnostic Automation, Inc. is a manufacturer and distributor of one step rapid tests & Elisa kits. We also offer IFA kits, chemiluminescence kits, serology tests and instruments. Chemiluminescence immunoassay (CLIA) detection using microplate luminometers provides a sensitive, high throughput alternative to conventional colorimetric methodologies, such as enzyme-linked immunosorbent assays (ELISA). Chemiluminescent immunoassay does not require long incubations or the addition of stopping reagents. The CLIA kits are designed to detect glow-based chemiluminescent reactions.

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• Methamphetamine Gas Chromatography Test (FDA Code: LAF / 862.3610) A methamphetamine test system is a device intended to measure methamphetamine, a central nervous system stimulating drug, in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of methamphetamine use or overdose.

• Morphine Liquid Chromatography Test (FDA Code: DPK / 862.3640) A morphine test system is a device intended to measure morphine, an addictive narcotic pain-relieving drug, and its analogs in serum, urine, and gastric contents. Measurements obtained by this device are used in the diagnosis and treatment of morphine use or overdose and in monitoring levels of morphine and its analogs to ensure appropriate therapy.

• Mouse Anti-Human Prostatic Acid Phosphatase (PSAP) Detection Kit

• 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)

• Mycoplasma Spp. Fluorescent Antisera (FDA Code: GRZ / 866.3375)

• Myoglobin (FDA Code: DDR / 866.5680) A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

• Myoglobin Enzyme Immunoassay Test Kit

• Myoglobin Radioimmunoassay Reagent Kits

• Myoglobin Ria Test Kit

• Non-Quantitative Urobilinogen Test (FDA Code: CDM / 862.1785) A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.

• Non-Treponemal Antigen (FDA Code: GMQ / 866.3820)

• Occult Blood in Urine Test (FDA Code: JIO / 864.6550) An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

• Occult Blood Reagent (FDA Code: KHE / 864.6550)

• Opiates Enzyme Immunoassay Test (FDA Code: DJG / 862.3650) An opiate test system is a device intended to measure any of the addictive narcotic pain-relieving opiate drugs in blood, serum, urine, gastric contents, and saliva. An opiate is any natural or synthetic drug that has morphine-like pharmocological actions. The opiates include drugs such as morphine, morphine glucoronide, heroin, codeine, nalorphine, and meperedine. Measurements obtained by this device are used in the diagnosis and treatment of opiate use or overdose and in monitoring the levels of opiate administration to ensure appropriate therapy.

• PAP Prostatic Acid Phosphatase (ELISA Kits)

• Phencyclidine Enzyme Immunoassay (FDA Code: LCM)

• Prolactin Radioimmunoassay (FDA Code: CFT / 862.1625) A prolactin (lactogen) test system is a device intended to measure the anterior pituitary polypeptide hormone prolactin in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of disorders of the anterior pituitary gland or of the hypothalamus portion of the brain.

• Prostate-Specific Antigen for Management of Prostate Cancers (FDA Code: LTJ / 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.

• Prostatic Acid Phosphatase

• Radioimmunoassay for Dehydroepiandrosterone Sulfate (FDA Code: JKC / 862.1245) A dehydroepiandrosterone (free and sulfate) test system is a device intended to measure dehydroepiandrosterone (DHEA) and its sulfate in urine, serum, plasma, and amniotic fluid. Dehydroepiandrosterone measurements are used in the diagnosis and treatment of DHEA-secreting adrenal carcinomas.

• Radioimmunoassay Kit For Prostatic Acid Phosphatase

• Rapid Test Tumor markers

• Rheumatoid Factor (RF)

• Rheumatoid Factor Test System (FDA Code: DHR / 866.5775) A rheumatoid factor immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the rheumatoid factor (antibodies to immunoglobulins) in serum, other body fluids, and tissues. Measurement of rheumatoid factor may aid in the diagnosis of rheumatoid arthritis.

• Rubella Enzyme Linked Immunoabsorbent Assay (FDA Code: LFX / 866.3510) Rubella virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubella virus in serum. The identification aids in the diagnosis of rubella (German measles) or confirmation of a person's immune status from past infections or immunizations and provides epidemiological information on German measles. Newborns infected in the uterus with rubella virus may be born with multiple congenital defects (rubella syndrome).

• Rubeola Enzyme Linked Immunoabsorbent Assay (FDA Code: LJB / 866.3520) Rubeola (measles) virus serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rubeola virus in serum. The identification aids in the diagnosis of measles and provides epidemiological information on the disease. Measles is an acute, highly infectious disease of the respiratory and reticuloendothelial tissues, particularly in children, characterized by a confluent and blotchy rash.

• Salivary Estradiol Enzyme Immunoassay Kit

• Salivary Testosterone Enzyme IMMUNOASSAY Kit

• Serum Prostatic Acid Phosphatase Test Kit

• Slide Culture Chamber (FDA Code: KIY / 864.2240) Cell and tissue culture supplies and equipment are devices that are used to examine, propagate, nourish, or grow cells and tissue cultures. These include such articles as slide culture chambers, perfusion and roller apparatus, cell culture suspension systems, and tissue culture flasks, disks, tubes, and roller bottles.

• Streptococcus Spp Antiserum (FDA Code: GTZ / 866.3740)

• Testosterone

• Testosterone Detection Kit

• Testosterone EIA Test Kit

• Testosterone ELISA Kit

• Testosterone Kits

• Testosterone Radioimmunoassay Test Kits

• Testosterones and Dihydrotestosterone Radioimmunoassay (FDA Code: CDZ / 862.1680) A testosterone test system is a device intended to measure testosterone (a male sex hormone) in serum, plasma, and urine. Measurement of testosterone are used in the diagnosis and treatment of disorders involving the male sex hormones (androgens), including primary and secondary hypogonadism, delayed or precocious puberty, impotence in males and, in females hirsutism (excessive hair) and virilization (masculinization) due to tumors, polycystic ovaries, and adrenogenital syndromes.

• Tetrahydrocannabinol Test (FDA Code: DKE / 862.3870) A cannabinoid test system is a device intended to measure any of the cannabinoids, hallucinogenic compounds endogenous to marihuana, in serum, plasma, saliva, and urine. Cannabinoid compounds includedelta -9-tetrahydrocannabinol, cannabidiol, cannabinol, and cannabichromene. Measurements obtained by this device are used in the diagnosis and treatment of cannabinoid use or abuse and in monitoring levels of cannabinoids during clinical investigational use.

• Thin Layer Chroomatography, Tricyclic Antidepressant Drugs (FDA Code: MLK / 862.3910) A tricyclic antidepressant drugs test system is a device intended to measure any of the tricyclic antidepressant drugs in serum. The tricyclic antidepressant drugs include imipramine, desipramine, amitriptyline, nortriptyline, protriptyline, and doxepin. Measurements obtained by this device are used in the diagnosis and treatment of chronic depression to ensure appropriate therapy.

• Thyroglobulin (FDA Code: DDC / 866.5870) A thyroid autoantibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the thyroid autoantibodies (antibodies produced against the body's own tissues). Measurement of thyroid autoantibodies may aid in the diagnosis of certain thyroid disorders, such as Hashimoto's disease (chronic lymphocytic thyroiditis), nontoxic goiter (enlargement of thyroid gland), Grave's disease (enlargement of the thyroid gland with protrusion of the eyeballs), and cancer of the thyroid.

• Thyroglobulin Autoantibody Immunochemical (FDA Code: JNL / 866.5870)

• Thyroid Autoantibody Test System (FDA Code: JZO / 866.5870)

• Thyroid Stimulating Hormone Radioimmunoassay (FDA Code: JLW / 862.1690) A thyroid stimulating hormone test system is a device intended to measure thyroid stimulating hormone, also known as thyrotrophin and thyrotrophic hormone, in serum and plasma. Measurements of thyroid stimulating hormone produced by the anterior pituitary are used in the diagnosis of thyroid or pituitary disorders.

• Thyroxine Binding Globulin Radioimmunoassay (FDA Code: CEE / 862.1685) A thyroxine-binding globulin test system is a device intended to measure thyroxine (thyroid)-binding globulin (TBG), a plasma protein which binds thyroxine, in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

• Total Thyroxine Non-Radiolabeled Enzyme Immunoassay (FDA Code: KLI / 862.1700) A total thyroxine test system is a device intended to measure total (free and protein bound) thyroxine (thyroid hormone) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases.

• Total Thyroxine Radioimmunoassay (FDA Code: CDX / 862.1700)

• Total Triiodothyronine Radioimmunoassay (FDA Code: CDP / 862.1710) A total triiodothyronine test system is a device intended to measure the hormone triiodothyronine in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of thyroid diseases such as hyperthyroidism.

• Toxoplasma Gondii Enzyme Linked Immunoabsorbent Assay (FDA Code: LGD / 866.3780)