Cliniqa Corporation

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Web: http://www.cliniqa.com
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Address: 1432 South Mission Road, Fallbrook, California 92028, USA
Phone: +1-(760)-744-1900, 800-728-5205 | Fax: +1-(760)-571-5197 | Map/Directions >>

Profile: Cliniqa Corporation produces and markets high quality antiserum, proteins, liquid controls & calibrator products that are designed to improve the accuracy of diagnostic tests. Our Liquid QC™ LiniCAL® calibration verifiers are intended for use in the clinical laboratory to objectively verify calibration and assess linearity regarding serum proteins on the beckman array protein systems. The liniCAL® calibration verifiers are convenient liquid stable serum protein matrices that are ready-to-use and store at 2-8° C. The five or six levels of assayed materials are designed for use with specific instrument platforms in order to challenge the low and high limits of the analyzer's reportable range. We are an ISO 9000/13485 certified company. We offer OEM proficiency test materials, Raichem reagents, standards and calibrators as well as forensic controls.

The company was founded in 1975, has revenues of USD 10-25 Million, has ~10 employees and is ISO 9001, CE certified.

FDA Registration Number: 2085064

29 Products/Services (Click for related suppliers)

• 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.

• Anti-acetylcholine Receptor Alpha Monoclonal Antibody

• Antistreptolysin-Titer/Streptolysin O Reagent (FDA Code: GTQ / 866.3720)

• 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.

• C-Reactive Protein (CRP), FITC Conjugate (FDA Code: DCK / 866.5270)

A C-reactive protein immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the C-reactive protein in serum and other body fluids. Measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues.

• 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.

• Controls for Diagnostic Equipment

• Discrete Photometric Chemistry Analyzer (FDA Code: JJE / 862.2160)

A discrete photometric chemistry analyzer for clinical use is a device intended to duplicate manual analytical procedures by performing automatically various steps such as pipetting, preparing filtrates, heating, and measuring color intensity. This device is intended for use in conjunction with certain materials to measure a variety of analytes. Different models of the device incorporate various instrumentation such as micro analysis apparatus, double beam, single, or dual channel photometers, and bichromatic 2-wavelength photometers. Some models of the device may include reagent-containing components that may also serve as reaction units.

• Enzyme Controls (FDA Code: JJT / 862.1660)

• General Diagnostic Supplies

• Glycosylated Hemoglobin Assay Test (FDA Code: LCP / 864.7470)

A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

• Haptoglobin (FDA Code: DAD / 866.5460)

A haptoglobin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the haptoglobin (a protein that binds hemoglobin, the oxygen-carrying pigment in red blood cells) in serum. Measurement of haptoglobin may aid in the diagnosis of hemolytic diseases (diseases in which the red blood cells rupture and release hemoglobin) related to the formation of hemoglobin-haptoglobin complexes and certain kidney diseases.

• LDL & VLDL Precipitation, Cholesterol Via Esterase-Oxidase (FDA Code: LBS / 862.1475)

A lipoprotein test system is a device intended to measure lipoprotein in serum and plasma. Lipoprotein measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases.

• Lipid Standard

• Monoclonal Antibody Test

• 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.)

• Polyclonal Antibody

• Polyclonal Antibody Goat Anti-HbsAg IgG

• Polyclonal Antibody Goat Anti-human IgG

• Polyclonal Antibody Goat Anti-mouse IgG

• Polyclonal Antibody Goat Anti-rabbit IgG

• Polyclonal Antibody Goat Anti-whole hCG

• 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.

• Secondary Calibrator (FDA Code: JIT / 862.1150)

• 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.

• Urinalysis Controls (FDA Code: JJW / 862.1660)