Iris Diagnostics

Address: 9172 Eton Avenue, Chatsworth, California 91311, USA
Phone: +1-(818)-709-1244 | Fax: +1-(818)-700-9661 | Map/Directions >>

Profile: Iris Diagnostics specializes in automated urinalysis technology. We produce clinical analyzers, which use real-time video flow imaging, displaying microscopic images on a video screen. Our systems are operated by a touch screen interfaces for use in urinalysis and microscopic analysis of body fluids. Our imaging systems use patented and proprietary automated intelligent microscopy technology for automating microscopic procedures, enabling clinical laboratory technologists to rapidly & efficiently analyze & process specimens automatically, significantly reducing the costly & time-consuming manual steps required for microscopic analysis.

The company was founded in 1979, has revenues of USD 50-100 Million, has ~90 employees and is CE certified. NASDAQ:IRIS (SEC Filings)

FDA Registration Number: 2023446

43 Products/Services (Click for related suppliers)  
• 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA / 862.1095)
An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies.
• Automated Cell Counter (FDA Code: GKL / 864.5200)
An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.
• Automated Slide Spinner (FDA Code: GKJ / 864.5850)
An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of peripheral blood (blood circulating in one of the body's extremities, such as the arm).
• Automated Urinalysis Chemistry Analyzer
• Automated Urinalysis System (FDA Code: KQO / 862.2900)
An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.
• Automated Urine Chemistry Analyzers
• Automated Urine Chemistry Analyzers
• Automated Urine Microscopy Analyzer
• Bilirubin and Conjugates Colorimetric Azo-Dyes Test (FDA Code: JJB / 862.1115)
A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.
• Blood Cell Diluent (FDA Code: GIF / 864.8200)
A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
• Capillary Blood Collection Tubes (FDA Code: GIO / 864.6150)
A capillary blood collection tube is a plain or heparinized glass tube of very small diameter used to collect blood by capillary action.
• Clinical Colorimeter (FDA Code: JJQ / 862.2300)
A colorimeter, a photometer, or a spectrophotometer for clinical use is an instrument intended to measure radiant energy emitted, transmitted, absorbed, or reflected under controlled conditions. The device may include a monochromator to produce light of a specific wavelength.
• Clinical Refractometer (FDA Code: JRE / 862.2800)
A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.
• Cytocentrifuge (FDA Code: IFB / 864.3300)
A cytocentrifuge is a centrifuge used to concentrate cells from biological cell suspensions (e.g., cerebrospinal fluid) and to deposit these cells on a glass microscope slide for cytological examination.
• 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.
• Electrical Urinometer (FDA Code: EXS / 876.1800)
A urine flow or volume measuring system is a device that measures directly or indirectly the volume or flow of urine from a patient, either during the course of normal urination or while the patient is catheterized. The device may include a drip chamber to reduce the risk of retrograde bacterial contamination of the bladder and a transducer and electrical signal conditioning and display equipment. This generic type of device includes the electrical urinometer, mechanical urinometer, nonelectric urinometer, disposable nonelectric urine flow rate measuring device, and uroflowmeter.
• General Purpose Reagent (FDA Code: LDT)
• Heating Block (FDA Code: JRG / 862.2050)
General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.
• Hematocrit Centrifuge (FDA Code: GKG / 864.6400)
A hematocrit measuring device is a system consisting of instruments, tubes, racks, and a sealer and a holder. The device is used to measure the packed red cell volume in blood to determine whether the patient's total red cell volume is normal or abnormal. Abnormal states include anemia (an abnormally low total red cell volume) and erythrocytosis (an abnormally high total red cell mass). The packed red cell volume is produced by centrifuging a given volume of blood.
• Hematocrit Measuring Device (FDA Code: JPI / 864.6400)
• Hematocrit Tube Rack (FDA Code: GHY / 864.6400)
• Hematology Quality Control Mixture (FDA Code: JPK / 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).
• Micro Surgery Instruments
• Micro Surgery Instruments, Graspers
• Micro Surgery Instruments, Pneumatic Power Systems
• Micro Surgery Instruments, Scissors
• Microbiological Stain (FDA Code: JTS / 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.
• 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)
• 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.
• 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.)
• Particle and Cell Urinalysis Systems
• Red Cell Lysing Fluid (FDA Code: GGK / 864.8540)
A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.
• Refrigerated Centrifuges (FDA Code: JQC / 862.2050)
• Urinalysis Controls (FDA Code: JJW / 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.
• Urinary Enzymatic Method (FDA Code: JIL / 862.1340)
A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.
• Urinary Ketones, Nitroprusside Test (FDA Code: JIN / 862.1435)
A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.
• Urinary Nitrite Colorimetric Test (FDA Code: JMT / 862.1510)
A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.
• Urinary pH Dye Indicator (FDA Code: CEN / 862.1550)
A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.
• Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR / 862.1645)
A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.
• Urine Chemistry Analyzers
• Urine Leukocyte Test (FDA Code: LJX / 864.7675)
A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.
• Urine Particle Counter (FDA Code: LKM / 864.5200)

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