Profile: Horiba designs and manufactures systems for analyzing & measuring liquids, gases and solids. Our ABX pentra 400 is an extremely compact clinical chemistry benchtop analyser, which is autonomy with continuous loading and also renders enchanced productivity in a user-friendly environment. The new ABX Micros ES60 haematology analyser is the perfect combination of intuitive use and innovative technology. Specially designed for point of care clinics, laboratories and emergency services, the next generation of the ABX Micros contains all the functions needed to manage results securely and easily through its new integrated workstation.

The company was founded in 1983, has revenues of USD 10-25 Million, has ~110 employees and is ISO certified.

FDA Registration Number: 1000256526
US Agent: Azita Hedayati / Horiba Instruments Incorporated (dba) Horiba Medical
Phone: +1-(888)-903-5001  E-Mail:

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• Myoglobin (FDA Code: DDR / 866.5680) A myoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the myoglobin (an oxygen storage protein found in muscle) in serum and other body fluids. Measurement of myoglobin aids in the rapid diagnosis of heart or renal disease.

• Nadh Oxidation/Nad Reduction (FDA Code: CKA / 862.1030) An alanine amino transferase (ALT/SGPT) test system is a device intended to measure the activity of the enzyme alanine amino transferase (ALT) (also known as a serum glutamic pyruvic transaminase or SGPT) in serum and plasma. Alanine amino transferase measurements are used in the diagnosis and treatment of certain liver diseases (e.g., viral hepatitis and cirrhosis) and heart diseases.

• Nitrophenylphosphate, Alkaline Phosphatase (FDA Code: CJE / 862.1050) An alkaline phosphatase or isoenzymes test system is a device intended to measure alkaline phosphatase or its isoenzymes (a group of enzymes with similar biological activity) in serum or plasma. Measurements of alkaline phosphatase or its isoenzymes are used in the diagnosis and treatment of liver, bone, parathyroid, and intestinal diseases.

• Platelet Counting Calibrator (FDA Code: KRY / 864.8175) A calibrator for platelet counting is a device that resembles platelets in plasma or whole blood and that is used to set a platelet counting instrument. It is a suspension of particles or cells whose size, shape concentration, and other characteristics have been precisely and accurately determined.

• Potassium Ion Specific Electrode (FDA Code: CEM / 862.1600) A potassium test system is a device intended to measure potassium in serum, plasma, and urine. Measurements obtained by this device are used to monitor electrolyte balance in the diagnosis and treatment of diseases conditions characterized by low or high blood potassium levels.

• Prealbumin Antiserum (FDA Code: JZJ / 866.5060) A prealbumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the prealbumin (a plasma protein) in serum and other body fluids. Measurement of prealbumin levels in serum may aid in the assessment of the patient's nutritional status.

• Primary Calibrator (FDA Code: JIS / 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.)

• Protein /Albumin Turbidimetric Method (FDA Code: JIQ / 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.

• 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).

• Red and White Cell Counting Calibrator (FDA Code: KSA / 864.8185) A calibrator for red cell and white cell counting is a device that resembles red or white blood cells and that is used to set instruments intended to count red cells, white cells, or both. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.

• 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.

• Refurbished Hematology Analyzers

• Secondary Calibrator (FDA Code: JIT / 862.1150)

• Smaller Hematology Analyzers

• Sodium Ion Specific Electrode (FDA Code: JGS / 862.1665) A sodium test system is a device intended to measure sodium in serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of aldosteronism (excessive secretion of the hormone aldosterone), diabetes insipidus (chronic excretion of large amounts of dilute urine, accompanied by extreme thirst), adrenal hypertension, Addison's disease (caused by destruction of the adrenal glands), dehydration, inappropriate antidiuretic hormone secretion, or other diseases involving electrolyte imbalance.

• Total Protein Biuret Method (FDA Code: CEK / 862.1635) A total protein test system is a device intended to measure total protein(s) in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of a variety of diseases involving the liver, kidney, or bone marrow as well as other metabolic or nutritional disorders.

• Triglycerides Lipase Hydrolysis/Glycerol Kinase Enzyme Test (FDA Code: CDT / 862.1705) A triglyceride test system is a device intended to measure triglyceride (neutral fat) in serum and plasma. Measurements obtained by this device are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism, or various endocrine disorders.

• Urea Nitrogen Urease and Glutamic Dehydrogenase Test (FDA Code: CDQ / 862.1770) A urea nitrogen test system is a device intended to measure urea nitrogen (an end-product of nitrogen metabolism) in whole blood, serum, plasma, and urine. Measurements obtained by this device are used in the diagnosis and treatment of certain renal and metabolic diseases.