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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• Rimmed Glass Test Tubes

• Sterile Specimen Mailer and Storage Container (FDA Code: KDT / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Storage Racks for Microscope Slide Boxes

• Test Tubes

• 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)

• Total Spinal Fluid Control (FDA Code: DFI / 866.5860) A total spinal fluid immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the total protein in cerebrospinal fluid. Measurement of spinal fluid proteins may aid in the diagnosis of multiple sclerosis and other diseases of the nervous system.

• 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.

• Urinalysis Test

• Urinary Drainage Collection Kit (FDA Code: FCN / 876.5250) A urine collector and accessories is a device intended to collect urine. The device and accessories consist of tubing, a suitable receptacle, connectors, mechanical supports, and may include a means to prevent the backflow of urine or ascent of infection. The two kinds of urine collectors are:

• Urine Screening Kit (FDA Code: JXA / 866.2660) A microorganism differentiation and identification device is a device intended for medical purposes that consists of one or more components, such as differential culture media, biochemical reagents, and paper discs or paper strips impregnated with test reagents, that are usually contained in individual compartments and used to differentiate and identify selected microorganisms. The device aids in the diagnosis of disease.