Phoenix Diagnostics, Inc.

Contact: Al Jordan - VP Marketing & Sales
Web: http://www.phoenixdiagnostics.com
Address: 8 Tech Circle, Natick, Massachusetts 01760, USA
Phone: +1-(508)-655-8310, 800-688-2595 | Fax: +1-(508)-655-8273 | Map/Directions >>

Profile: Phoenix Diagnostics, Inc. is a manufacturer of consumables for blood gas, electrolyte, co-oximetry, and chemistry analyzers. We focus on the private-label manufacturing of quality controls and calibration verification materials for leading in vitro diagnostics companies. Our replacements reagents, calibration packs, and electrodes are designed for use with blood gas, electrolyte, co-oximetry, and chemistry analyzers

The company was founded in 1989, has revenues of < USD 1 Million.

FDA Registration Number: 1222035

11 Products/Services (Click for related suppliers)

• 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 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.

• Calibration Reagent

• 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.

• Contract Manufacturing

• Electrolyte Control (FDA Code: JJR / 862.1660)

• Enzyme Controls (FDA Code: JJT / 862.1660)

• Multi Analyte Control (FDA Code: JJY / 862.1660)

• Multi Analyte Mixture - Calibrator (FDA Code: JIX / 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.)

• 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.