Innominata dba GenBio

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Web: http://www.genbio.com
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Address: 15222-A Avenue of Science, San Diego, California 92128, USA
Phone: +1-(858)-592-9300 | Fax: +1-(858)-592-9400 | Map/Directions >>

Profile: Innominata dba GenBio produces serology immunoassays for laboratory use. We are accredited with ISO 13485 certification. We offer products like immunoDOT, immunoWELL, immunoFLOW & immunoFA. Our immunodot is a proprietary assay system, which simultaneously detects six analytes. Our immunowell microtiter assay system is optimized to work in small & automated laboratories. Our immunofa toxoplasma renders toxoplasma indirect immunofluorescent assays (IFA). We also deliver torches (toxoplasma, rubella, CMV and HSV) in our immunodot format.

The company has revenues of USD 1-5 Million, has ~20 employees and is CE certified.

FDA Registration Number: 2027113

36 Products/Services (Click for related suppliers)

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

• ANA (Antinuclear antibodies)

• Anti-RNP Antibody (FDA Code: LKO / 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).

• Anti-SM-Antibody (FDA Code: LKP / 866.5100)

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

• Antinuclear Antibody, Indirect Immunofluorescen (FDA Code: DHN / 866.5100)

• Automated Microtiter Plate ELISA Reader

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

• 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)

• Diagnostic Devices

• ELISA Microtiter Plate Immunoanalyzer

• Enzyme Immunoassay Chemistry Analyzer

• 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 IF Antibody IGM (FDA Code: LJN / 866.3235)

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

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

• HIV Antibody Test Kits

• 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)

• Immunoassays

• Immunological Anticardiolipin Test System (FDA Code: MID / 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).

• Leptospira Spp Antigen (FDA Code: GRY / 866.3350)

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

• Pregnancy Kits

• Pregnancy Test Strip (Urine/Serum)

• Rickettsia Serological Reagents (FDA Code: LSQ / 866.3500)

Rickettsia serological reagents are devices that consist of antigens and antisera used in serological tests to identify antibodies to rickettsia in serum. Additionally, some of these reagents consist of rickettsial antisera conjugated with a fluorescent dye (immunofluorescent reagents) used to identify rickettsia directly from clinical specimens. The identification aids in the diagnosis of diseases caused by virus-like bacteria belonging to the genusRickettsiae and provides epidemiological information on these diseases. Rickettsia are generally transmitted by arthropods (e.g., ticks and mosquitoes) and produce infections in humans characterized by rash and fever (e.g., typhus fever, spotted fever, Q fever, and trench fever).

• 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).

• Salmonella Spp Antiserum (FDA Code: GRM / 866.3550)

• Systemic Lupus Erythematosus Test (FDA Code: DHC / 866.5820)

A systemic lupus erythematosus (SLE) immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the autoimmune antibodies in serum and other body fluids that react with cellular nuclear double-stranded deoxyribonucleic acid (DNA) or other nuclear constituents that are specifically diagnostic of SLE. Measurement of nuclear double-stranded DNA antibodies aids in the diagnosis of SLE (a multisystem autoimmune disease in which tissues are attacked by the person's own antibodies).

• Thyroglobulin Autoantibody Immunochemical (FDA Code: JNL / 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.

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

• Toxoplasma Gondii IF Antigen Test (FDA Code: GLZ / 866.3780)

• Toxoplasma Gondii IF Antisera Test (FDA Code: LJK / 866.3780)

• Whole Human Serum (FDA Code: DGR / 866.5700)

A whole human plasma or serum immunological test system is a device that consists of reagents used to measure by immunochemical techniques the proteins in plasma or serum. Measurements of proteins in plasma or serum aid in the diagnosis of any disease concerned with abnormal levels of plasma or serum proteins, e.g., agammaglobulinemia, allergies, multiple myeloma, rheumatoid vasculitis, or hereditary angioneurotic edema.