Profile: Epocal, Inc supplies biochips and micro-fabrication of diagnostic devices. We are implementing the entire blood diagnostic system in Flexcard™ and manufactures cards at ultra low cost, leveraging already existing volume and low cost production technologies for smart cards. Our Epoc™ caters of comprising diagnostic test cards and wireless card readers. This Epoc™ requires no refrigeration of consumables to accurate and immediate bedside results. It keeps caregivers at the bedside. Our single-use bar code identified units containing a biosensor array, calibration solution and fluidics. This smart card technology caters of epoc test cards currently in development include additional blood chemistries, hemostasis, and hematology immunoassay panels. We also used as room temperature storage, integrated calibration and quality checks, barcoded for error-free panel identification & lot number, and inventory records.
FDA Registration Number: 3004959793
US Agent: Andrew Froio / Siemens Healthcare Diagnostics Inc.
Phone: +1-(508)-558-1930 E-Mail:
8 Products/Services (Click for related suppliers)
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• 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. |
• 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). |
• 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. |
• 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. |
• Hematocrit Measuring Device (FDA Code: JPI / 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. |
• 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). |
• 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. |
• 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. |