Profile: Organon Teknika B.V. manufactures HIV diagnostic products, including NucliSens® HIV-1 viral load and nucliSens HIV-1 RNA detection assays. Our product line includes nucleic acid sequence-based HIV assays.

The company has revenues of USD 100-500 Million, has ~2250 employees and is ISO 9001, CE certified. NASDAQ:AKZOY (SEC Filings)

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• Acetylcholine Chloride Reagent (FDA Code: DLI / 862.3240) A cholinesterase test system is a device intended to measure cholinesterase (an enzyme that catalyzes the hydrolysis of acetylcholine to choline) in human specimens. There are two principal types of cholinesterase in human tissues. True cholinesterase is present at nerve endings and in erythrocytes (red blood cells) but is not present in plasma. Pseudo cholinesterase is present in plasma and liver but is not present in erythrocytes. Measurements obtained by this device are used in the diagnosis and treatment of cholinesterase inhibition disorders (e.g., insecticide poisoning and succinylcholine poisoning).

• Acid Fuchsin Stain (FDA Code: IDF / 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.

• Acid Phosphatase, Naphthyl Phosphate Test (FDA Code: CKB / 862.1020) An acid phosphatase (total or prostatic) test system is a device intended to measure the activity of the acid phosphatase enzyme in plasma and serum.

• Acid, Hydroxyazobenzene-Benzoic, Albumin (FDA Code: CJZ / 862.1035) An albumin test system is a device intended to measure the albumin concentration in serum and plasma. Albumin measurements are used in the diagnosis and treatment of numerous diseases involving primarily the liver or kidneys.

• Activated Partial Thromboplastin (FDA Code: GFO / 864.7925) A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

• Agar Tube Test

• Air Bubble Detectors (FDA Code: FJF / 876.5820) A hemodialysis system and accessories is a device that is used as an artificial kidney system for the treatment of patients with renal failure or toxemic conditions and that consists of an extracorporeal blood system, a conventional dialyzer, a dialysate delivery system, and accessories. Blood from a patient flows through the tubing of the extracorporeal blood system and accessories to the blood compartment of the dialyzer, then returns through further tubing of the extracorporeal blood system to the patient. The dialyzer has two compartments that are separated by a semipermeable membrane. While the blood is in the blood compartment, undesirable substances in the blood pass through the semipermeable membrane into the dialysate in the dialysate compartment. The dialysate delivery system controls and monitors the dialysate circulating through the dialysate compartment of the dialyzer.

• Air Bubble Monitor (FDA Code: FJF / 876.5820)

• Albumin Antigen Antiserum Control (FDA Code: DCF / 866.5040) An albumin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the albumin (a plasma protein) in serum and other body fluids. Measurement of albumin aids in the diagnosis of kidney and intestinal diseases.

• Aldolase Hydrazone Colorimetry Test (FDA Code: CJT / 862.1040) An aldolase test system is a device intended to measure the activity of the enzyme aldolase in serum or plasma. Aldolase measurements are used in the diagnosis and treatment of the early stages of acute hepatitis and for certain muscle diseases such as progressive Duchenne-type muscular dystrophy.

• Alkaline Phosphatase, Phenolphthalein Phosphate Test (FDA Code: CJK / 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.

• Amylase Starch-Dye Bound Polymer Test (FDA Code: CIW / 862.1070) An amylase test system is a device intended to measure the activity of the enzyme amylase in serum and urine. Amylase measurements are used primarily for the diagnosis and treatment of pancreatitis (inflammation of the pancreas).

• Amyloclastic, Amylase (FDA Code: CJA / 862.1070)

• Anti-acetylcholine Receptor Alpha Monoclonal Antibody

• Apheresis Equipment

• Automated Coagulation Analyzer (FDA Code: GKP / 864.5400) A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

• Automated Coagulation Instrument (FDA Code: GKP / 864.5400)

• Bacterial Diagnostic Test

• Bilirubin Diazo Colorimetry Test (FDA Code: CIG / 862.1110) A bilirubin (total or direct) test system is a device intended to measure the levels of bilirubin (total or direct) in plasma or serum. Measurements of the levels of bilirubin, an organic compound formed during the normal and abnormal distruction of red blood cells, if used in the diagnosis and treatment of liver, hemolytic hematological, and metabolic disorders, including hepatitis and gall bladder block.

• Bleeding Time Device (FDA Code: JCA / 864.6100) A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets.

• Blood Clot Coagulation Analyzer (FDA Code: GKP / 864.5400)

• 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.

• Blood Gas Controls (FDA Code: JJS / 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.

• Blood Urea Nitrogen (BUN) Reagent

• Coagulation Analyzer with Timer (FDA Code: GKP / 864.5400)

• Coagulation Analyzers (FDA Code: GKP / 864.5400)

• Coagulation Factor Deficient Plasma (FDA Code: GJT / 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).

• Computer Softwares

• Control Thromboplastin Reagent (FDA Code: GGO / 864.7925)

• Cortisol Radioimmunoassay Test (FDA Code: CGR / 862.1205) A cortisol (hydrocortisone and hydroxycorticosterone) test system is a device intended to measure the cortisol hormones secreted by the adrenal gland in plasma and urine. Measurements of cortisol are used in the diagnosis and treatment of disorders of the adrenal gland.

• Cytochemical, Acid Phosphatase (FDA Code: JCI / 864.1850)

• Diagnostic Automated Blood Cell Separator (FDA Code: GKT / 864.9245)

• Dialysate Tubing Connector (FDA Code: FKY / 876.5820)

• Electrophoresis Apparatus (FDA Code: JJN / 862.2485) An electrophoresis apparatus for clinical use is a device intended to separate molecules or particles, including plasma proteins, lipoproteins, enzymes, and hemoglobulins on the basis of their net charge in specified buffered media. This device is used in conjunction with certain materials to measure a variety of analytes as an aid in the diagnosis and treatment of certain disorders.

• ENT Computer Software

• Enterobacteriaceae Identification Kit (FDA Code: JSS / 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.

• Extra-Luminal Blood Pump (FDA Code: FIR / 876.5820)

• Fertility Monitors, Pregnancy Test Kits

• Fibrinogen Determination Standard and Control (FDA Code: GFK / 864.7340) A fibrinogen determination system is a device that consists of the instruments, reagents, standards, and controls used to determine the fibrinogen levels in disseminated intravascular coagulation (nonlocalized clotting within the blood vessels) and primary fibrinolysis (the dissolution of fibrin in a blood clot).

• Fibrinogen Standard (FDA Code: GFX / 864.7340)

• Fully Automated Random Access Coagulation Analyzer

• Glucose Hexokinase Test (FDA Code: CFR / 862.1345) A glucose test system is a device intended to measure glucose quantitatively in blood and other body fluids. Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma.

• Glucose Orthotoluidine Test (FDA Code: CGE / 862.1345)

• Glucose Oxidase, Glucose (FDA Code: CGA / 862.1345)

• Hemodialysis Unit Air Bubble-Foam Detector

• Hemodialysis Unit Blood Pump

• Hemodialysis Unit Conductivity Monitor

• Hemodialysis Units

• Hepatitis B Antigen Identification System (FDA Code: KSJ)

• Hollow Fiber Capillary Dialyzer (FDA Code: FJI / 876.5820)