Analyticon Biotechnologies Ag

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Contact: Klaus Langer
Web: http://www.analyticon-diagnostics.com
E-Mail:
Address: Am Muehlenberg 10, Lichtenfels 35104, Germany
Phone: +49-(64)-547-991 | Fax: +43-(64)-547-991 | Map/Directions >>

Profile: Analyticon Biotechnologies Ag manufactures diagnostic systems. Our clinical products include analyzer, urinalysis, clinical chemistry, rapid slide tests and diabetes products. Our analyzers comprise of Combiscan 100, Combiscan XL, Biolyzer 100 and Biolyzer 200. Our Combiscan 100 is a semi automated urine test strip analyzer for use with Combiscreen 11SYS or 11SYS PLUS test strips. It is designed for physician office and for smaller laboratories.

FDA Registration Number: 3003775076
US Agent: Maureen N. Garner / New World Regulatory Solutions, Inc.
Phone: +1-(732)-929-4803 Fax: +1-(732)-270-4829 E-Mail:

16 Products/Services (Click for related suppliers)

• 4-dinitrophenylhydrazine 2 Ascorbic Acid (FDA Code: JMA / 862.1095)

An ascorbic acid test system is a device intended to measure the level of ascorbic acid (vitamin C) in plasma, serum, and urine. Ascorbic acid measurements are used in the diagnosis and treatment of ascorbic acid dietary deficiencies.

• Automated Urinalysis System (FDA Code: KQO / 862.2900)

An automated urinalysis system is a device intended to measure certain of the physical properties and chemical constituents of urine by procedures that duplicate manual urinalysis systems. This device is used in conjunction with certain materials to measure a variety of urinary analytes.

• Bilirubin and Conjugates Colorimetric Azo-Dyes Test (FDA Code: JJB / 862.1115)

A urinary bilirubin and its conjugates (nonquantitative) test system is a device intended to measure the levels of bilirubin conjugates in urine. Measurements of urinary bilirubin and its conjugates (nonquantitative) are used in the diagnosis and treatment of certain liver diseases.

• Calibrators

• Clinical Refractometer (FDA Code: JRE / 862.2800)

A refractometer for clinical use is a device intended to determine the amount of solute in a solution by measuring the index of refraction (the ratio of the velocity of light in a vacuum to the velocity of light in the solution). The index of refraction is used to measure the concentration of certain analytes (solutes), such a plasma total proteins and urinary total solids. Measurements obtained by this device are used in the diagnosis and treatment of certain conditions.

• Diabetes Test

• Non-Quantitative Urobilinogen Test (FDA Code: CDM / 862.1785)

A urinary urobilinogen (nonquantitative) test system is a device intended to detect and estimate urobilinogen (a bile pigment degradation product of red cell hemoglobin) in urine. Estimations obtained by this device are used in the diagnosis and treatment of liver diseases and hemolytic (red cells) disorders.

• Occult Blood in Urine Test (FDA Code: JIO / 864.6550)

An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

• Urinalysis Kits

• Urinary Enzymatic Method (FDA Code: JIL / 862.1340)

A urinary glucose (nonquantitative) test system is a device intended to measure glucosuria (glucose in urine). Urinary glucose (nonquantitative) measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, hypoglycemia, and hyperglycemia.

• Urinary Ketones, Nitroprusside Test (FDA Code: JIN / 862.1435)

A ketones (nonquantitative) test system is a device intended to identify ketones in urine and other body fluids. Identification of ketones is used in the diagnosis and treatment of acidosis (a condition characterized by abnormally high acidity of body fluids) or ketosis (a condition characterized by increased production of ketone bodies such as acetone) and for monitoring patients on ketogenic diets and patients with diabetes.

• Urinary Nitrite Colorimetric Test (FDA Code: JMT / 862.1510)

A nitrite (nonquantitative) test system is a device intended to identify nitrite in urine. Nitrite identification is used in the diagnosis and treatment of uninary tract infection of bacterial origin.

• Urinary Occult Blood Enzymatic Method (FDA Code: JIP / 864.6550)

• Urinary pH Dye Indicator (FDA Code: CEN / 862.1550)

A urinary pH (nonquantitative) test system is a device intended to estimate the pH of urine. Estimations of pH are used to evaluate the acidity or alkalinity of urine as it relates to numerous renal and metabolic disorders and in the monitoring of patients with certain diets.

• 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.

• Urine Leukocyte Test (FDA Code: LJX / 864.7675)

A leukocyte peroxidase test is a device used to distinguish certain myeloid cells derived from the bone marrow, i.e., neutrophils, eosinophils, and monocytes, from lymphoid cells of the lymphatic system and erythroid cells of the red blood cell series on the basis of their peroxidase activity as evidenced by staining. The results of this test are used in the differential diagnosis of the leukemias.