Corgenix, Inc.

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Web: http://www.corgenixonline.com
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Address: 12061 Tejon St, Westminster, Colorado 80234, USA
Phone: +1-(303)-457-4345 | Fax: +1-(303)-457-4519 | Map/Directions >>

Profile: Corgenix,Inc develops and manufactures diagnostic test kits that are used to aid in the diagnosis of specific immunological diseases. We offer products like anti phospholipids products, autoimmune products, Hemostasis products, gastroenterological products & platlet function products. Our hyaluronic acid (HA) quantitative test kit is an enzyme linked binding protein assay for the quantitative determination of hyaluronic acid (HA) in human serum or plasma. The anti-SS-A test is a qualitative or quantitative indirect enzyme immunoassay for the detection of autoantibodies specific for SS-A (Ro) antigen in human serum or plasma. The test is intended as an aid in the diagnosis of systemic rheumatic disease, particularly syndrome and is not definitive in isolation.

FDA Registration Number: 1721937

40 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.

• ANA (Antinuclear antibodies)

• 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-Beta 2 Glycoprotein 1 IgG ELISA Kit

• Anti-Cardiolipin IgA ELISA Kit

• Anti-Cardiolipin IgG ELISA Kit

• Anti-Centromere Test

• Anti-Mitochondrial Test

• Anti-Phosphatidylserine IgA ELISA Kit

• Anti-Phosphatidylserine IgG ELISA Kit

• Anti-Phosphatidylserine IgM ELISA Kit

• Anti-Phospholipid Products

• Anti-Prothrombin Antibody IgG ELISA Kit

• Anti-Prothrombin Antibody IgM ELISA Kit

• 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)

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

• Antinuclear Antibody (ANA) ELISA Screen

• B2 - Glycoprotein I Antibodies Test System (FDA Code: MSV / 866.5660)

• Coagulation Test Kits

• Compliance Resources, Clinical Lab

• Compliance Service, FDA

• Consultants, Regulatory Assistance

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

• Diagnostic Test Kits

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

• General Purpose Reagent (FDA Code: LDT)

• Hemostasis Products

• Immunological Anticardiolipin Test System (FDA Code: MID / 866.5660)

• 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).

• Laboratory Automation Systems

• Neurology Instruments

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

• Platelet Function Products

• Publications

• Publications Service

• Qualitative and Quantitative Factor Deficiency Test (FDA Code: GGP / 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).

• 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).

• Urinary 11-Dehydro Thromboxane B2 Kit (FDA Code: OBW / 864.5700)

An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.