Analytical Control Systems, Inc.

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Contact: Dean Bonderman - President
Web: http://www.analyticalcontrols.com
E-Mail:
Address: 9058 Technology Drive, Fishers, Indiana 46038, USA
Phone: +1-(317)-841-0458 | Fax: +1-(317)-841-3186 | Map/Directions >>

Profile: Analytical Control Systems, Inc. is a manufacturer of diagnostic controls, reagents and test products. We offer newborn screening products such as gal-1-put, hemoglobin variant controls such as AF, AS, AC, AD, AE, AFS, AFC, AFSC, NAFSC, HAFSC and A2, demoglobin variant control set & erythro-6-dehydrogenase G-6-PDH controls.

The company was founded in 1978, has revenues of USD 1-5 Million.

FDA Registration Number: 1825740

13 Products/Services (Click for related suppliers)

• Abnormal Plasma Control (FDA Code: GGC / 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.

• 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.

• Alkali Resistant Hemoglobin (FDA Code: GHA / 864.7455)

A fetal hemoglobin assay is a device that is used to determine the presence and distribution of fetal hemoglobin (hemoglobin F) in red cells or to measure the amount of fetal hemoglobin present. The assay may be used to detect fetal red cells in the maternal circulation or to detect the elevated levels of fetal hemoglobin exhibited in cases of hemoglobin abnormalities such as thalassemia (a hereditary hemolytic anemia characterized by a decreased synthesis of one or more types of hemoglobin polypeptide chains). The hemoglobin determination may be made by methods such as electrophoresis, alkali denaturation, column chromatography, or radial immunodiffusion.

• 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.

• Control Thromboplastin Reagent (FDA Code: GGO / 864.7925)

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

• Multipurpose System for Invitro Coagulation Studies (FDA Code: JPA / 864.5425)

• Normal Control Plasma (FDA Code: GIZ / 864.5425)

• Plasma Coagulation Control (FDA Code: GGN / 864.5425)

• Quality Control Reagent

• Reagent & Control Partial Thromboplastin Time (FDA Code: GIT / 864.7925)

• Reagents