Axis-Shield USA

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Contact: John Sperzel
Web: http://www.axis-shield-poc.com
E-Mail:
Address: 10 Commerce Way, Norton, Massachusetts 02766, USA
Phone: +1-(508)-2854870 | Fax: +1-(508)-2854840 | Map/Directions >>

Profile: Axis-Shield USA is a healthcare company comprising a laboratory and a point of care business backed by a R&D division. We develop, manufacture, & market sales of in-vitro diagnostic products. Our several unique products are Thrombotest™, Lymphoprep™ as well as NycoCard™ & Afinion&rade;, two product portfolios for use in the point of care segment. We specialize in distributing Afinion AS100 analyzer. Afinion AS100 analyzer is a small bench top, multi-assay analyzer for in-vitro diagnostic point of care testing. The Afinion HbA1c test cartridge is self contained, with all necessary reagents, and is equipped with an integrated sampling device. The Afinion AS100 analyzer is simple, fast, and reliable with its features like no interference from hemoglobin variants & fail safe mechanism prevents reporting of erroneous results.

The company was founded in 2005.

9 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.

• 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.

• Calibrators

• 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.

• 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.

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

• Reflectance Densitometer/Scanner (FDA Code: JQT / 862.2400)

A densitometer/scanner (integrating, reflectance, thin-layer chromatography, or radiochromatogram) for clinical use is device intended to measure the concentration of a substance on the surface of a film or other support media by either a photocell measurement of the light transmission through a given area of the medium or, in the case of the radiochromatogram scanner, by measurement of the distribution of a specific radio-active element on a radiochromatogram.

• Urinary Protein/Albumin Nonquantitative Test System (FDA Code: JIR / 862.1645)

A urinary protein or albumin (nonquantitative) test system is a device intended to identify proteins or albumin in urine. Identification of urinary protein or albumin (nonquantitative) is used in the diagnosis and treatment of disease conditions such as renal or heart diseases or thyroid disorders, which are characterized by proteinuria or albuminuria.