Hycor Biomedical Inc.

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Web: http://www.hycorbiomedical.com
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Address: 7272 Chapman Avenue, Garden Grove, California 92841, USA
Phone: +1-(714)-933-3000 | Fax: +1-(714)-933-3222 | Map/Directions >>
 
 

Profile: Hycor Biomedical Inc. manufactures diagnostic products and distributes to clinical laboratories. We offer products like allergy testing, autoimmune testing, urinalysis, infectious disease healthcare professionals. Our kova glasstic slide 10 is a ten chamber, disposable microscope slide made of optically clear plastic. Our kova-trol is a premier urine dipstick chemistry control that offers 18- month refrigerated stability. Our refractrol SP is a tri-level control product designed for use with temperature compensated and non compensated refractometers.

FDA Registration Number: 2016473

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• Allergy Reagents & Test Kits
• Allergy Test
• Allergy Testing
• Anti-Gliadin (Ab)
• Anti-Gliadin (Ab) IgA Kit
• Anti-Gliadin (Ab) IgG Kit
• Anti-MPO ANCA
• Anti-MPO ANCA EIA Auto-Immune Markers Testing 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)
• 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)
• Antiparietal Cell Antibody Antigen Control, Enzyme Immunoassay (FDA Code: MLE / 866.5110)
An antiparietal antibody immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the specific antibody for gastric parietal cells in serum and other body fluids. Gastric parietal cells are those cells located in the stomach that produce a protein that enables vitamin B12to be absorbed by the body. The measurements aid in the diagnosis of vitamin B12deficiency (or pernicious anemia), atrophic gastritis (inflammation of the stomach), and autoimmune connective tissue diseases (diseases resulting when the body produces antibodies against its own tissues).
• 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.
• B2 - Glycoprotein I Antibodies Test System (FDA Code: MSV / 866.5660)
• Blood Collection Systems (FDA Code: JKA / 862.1675)
A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.
• Campylobacter Pylori (FDA Code: LYR / 866.3110)
• Control Antigen Antinuclear Antibody (FDA Code: LKJ / 866.5100)
• Controls
• Data Processing Module for Clinical use (FDA Code: JQP / 862.2100)
A calculator/data processing module for clinical use is an electronic device intended to store, retrieve, and process laboratory data.
• Drug Mixture Control Materials (FDA Code: DIF / 862.3280)
A clinical toxicology control material is a device intended to provide an estimation of the precision of a device test system and to detect and monitor systematic deviations from accuracy resulting from reagent or instrument defects. This generic type of device includes various single, and multi-analyte control materials.
• Endomysial Autoantibodies (FDA Code: MVM / 866.5660)
• Enzyme Labeled Anti-DNA Antibody (FDA Code: LRM / 866.5100)
• Enzyme Labeled Antinuclear Antibody (FDA Code: LJM / 866.5100)
• General Diagnostic Supplies
• General Diagnostics
• General Medical Supplies
• Giant Test Tubes
• Gliadin Antibodies (FDA Code: MST / 866.5750)
A radioallergosorbent immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the allergen antibodies (antibodies which cause an allergic reaction) specific for a given allergen. Measurement of specific allergen antibodies may aid in the diagnosis of asthma, allergies, and other pulmonary disorders.
• Hematocrit Control (FDA Code: GLK / 864.8625)
A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).
• Hematology Quality Control Mixture (FDA Code: JPK / 864.8625)
• Hemoglobin Control (FDA Code: GGM / 864.8625)
• Histology Crystal Violet Stain (FDA Code: ICF / 864.1850)
Dye and chemical solution stains for medical purposes are mixtures of synthetic or natural dyes or nondye chemicals in solutions used in staining cells and tissues for diagnostic histopathology, cytopathology, or hematology.
• 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).
• Infectious Disease Exams
• Microscope Slide Boxes
• Microscope Slide Dispenser
• Microscope Slide Drawer
• Microscope Slide Staining Kit
• Microscope Slide Storage Cabinets
• Microscope Slides (FDA Code: KEW / 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.
• Microscope Slides (FDA Code: KEW / 864.3010)
• Multi Analyte Mixture - Calibrator (FDA Code: JIX / 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.)
• Normal and Abnormal Cell Counter Control (FDA Code: JCN / 864.8625)
• Pipetting and Diluting Station (FDA Code: JQW / 862.2750)
A pipetting and diluting system for clinical use is a device intended to provide an accurately measured volume of liquid at a specified temperature for use in certain test procedures. This generic type of device system includes serial, manual, automated, and semi-automated dilutors, pipettors, dispensers, and pipetting stations.
• Pyrex Test Tubes
• Radio-Allergen Absorbent (RAST) Test (FDA Code: DHB / 866.5750)
• 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.

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