Profile: International Technidyne Corp. specializes in the fields of hemostasis management and point-of-care testing. Our products include Hemochron® whole blood coagulation system, Tenderfoot®heel incision device, Tenderlett® finger incision device, Surgicutt® bleeding time device, and ProTime® microcoagulation system. Our Tenderlett® finger incision devices are designed to fit the contour of the finger. It produces a standardized length and depth incision with every procedure, color-coded for easy identification, available only in adult size. Our hemochron cuvette technology is based around our low blood volume microcoaglulation testing cuvettes. Our Irma Trupoint® is a self contained system that can be easily transported from OR to CCU to ICU or wherever needed for immediate results and more timely interventions.

The company has revenues of USD 25-50 Million, has ~300 employees and is ISO 9001, CE certified. NASDAQ:TMO (SEC Filings)

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• 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.

• Activated Whole Blood Clotting Time (FDA Code: JBP / 864.7140) An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.

• Artery Blood Sampling Kits

• 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.

• Automated Clot Timer (FDA Code: GKN / 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 Analyzer (FDA Code: GKP / 864.5400)

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

• Automated Hematocrit Instrument (FDA Code: GKF / 864.5600) An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

• Automated Hemoglobin System (FDA Code: GKR / 864.5620) An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

• 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 Coagulation Systems

• Blood Collection Lancet (FDA Code: FMK / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Blood Collection Needles

• 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 & Electrolyte Analyzers

• Blood Gas Analyzers

• Blood Gas and Ph Electrode Measurement (FDA Code: CHL / 862.1120) A blood gases (PCO2, PO2) and blood pH test system is a device intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma. Measurements of blood gases (PCO2, PO2) and blood pH are used in the diagnosis and treatment of life-threatening acid-base disturbances.

• Blood Lancet Needle (Blade Type)

• Blood Lancet Needle (Pen Type)

• Blood Lancets

• Blood Microcoagulation System

• Blood Sampling Kit

• Blood, Hemoglobin Analyzers

• Calcium Ion Specific Electrode (FDA Code: JFP / 862.1145) A calcium test system is a device intended to measure the total calcium level in serum. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms).

• Carbon-Monoxide Oxyhemoglobin/Carboxyhemoglobin Curve Test (FDA Code: JKS / 862.3220) A carbon monoxide test system is a device intended to measure carbon monoxide or carboxyhemoglobin (carbon monoxide bound to the hemoglobin in the blood) in blood. Measurements obtained by this device are used in the diagnosis and treatment of or confirmation of carbon monoxide poisoning.

• Chloride Ion Specific Electrode (FDA Code: CGZ / 862.1170) A chloride test system is a device intended to measure the level of chloride in plasma, serum, sweat, and urine. Chloride measurements are used in the diagnosis and treatment of electrolyte and metabolic disorders such as cystic fibrosis and diabetic acidosis.

• Co-Oximeter

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

• Coagulation Analyzers (FDA Code: GKP / 864.5400)

• Coagulation Instrument (FDA Code: KQG / 864.5400)

• Coagulation Timer (FDA Code: JBT / 864.5400)

• Creatinine Enzymatic Method Test (FDA Code: JFY / 862.1225) A creatinine test system is a device intended to measure creatinine levels in plasma and urine. Creatinine measurements are used in the diagnosis and treatment of renal diseases, in monitoring renal dialysis, and as a calculation basis for measuring other urine analytes.

• Cuvette

• Disposable Blood Lancet Needles

• Double-Ended Blood Collection Needle

• Dry and Liquid Heparin Arterial Blood Sampling Kits

• Fibrinogen Determination System Test (FDA Code: KQJ / 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).

• Finger Incision Devices

• Glucose Oxidase, Glucose (FDA Code: CGA / 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.

• Heel Incision Devices

• 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.

• Hemoglobin Analyzers

• Hemoglobin Testing Systems

• Hemostasis Management System

• Hemostasis Products

• Heparin Assay (FDA Code: KFF / 864.7525) A heparin assay is a device used to determine the level of the anticoagulant heparin in the patient's circulation. These assays are quantitative clotting time procedures using the effect of heparin on activated coagulation factor X (Stuart factor) or procedures based on the neutralization of heparin by protamine sulfate (a protein that neutralizes heparin).

• Lactic Acid Enzymatic Method (FDA Code: KHP / 862.1450) A lactic acid test system is a device intended to measure lactic acid in whole blood and plasma. Lactic acid measurements that evaluate the acid-base status are used in the diagnosis and treatment of lactic acidosis (abnormally high acidity of the blood).

• Medical Absorbent Fiber (FDA Code: FRL / 880.5300) A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.

• Multipurpose System for Invitro Coagulation Studies (FDA Code: JPA / 864.5425) A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.