Chromsystems Instruments & Chemicals Gmbh

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Contact: Andreas Groemping
Web: http://www.chromsystems.de
E-Mail:
Address: Heimburgstrasse 3, Munich 81243, Germany
Phone: +49-(89)-18930200 | Fax: +49-(89)-18930299 | Map/Directions >>

Profile: Chromsystems Instruments & Chemicals Gmbh specializes in the manufacture of products for routine clinical diagnostic applications. Our products include CDT, homocysteines, vitamin D3/D2 crosslinks, biogenic amines, occupational medicines, multilevel calibrator sets, HPLC-instruments and HPLC- softwares. We provide range of services that comprise of monitoring oxidative stress, newborn screening, vitamin profiling, therapeutic drug nonitoring, porphyrin profiling, hemoglobin-testing, controls for quality assurance, controls TDM, calibrators quality assurance and calibrators TDM.

The company is ISO 9001:2008, ISO 13485:2003 certified.

FDA Registration Number: 3003951180
US Agent: Ronald Arkin / Arkin Consulting Group
Phone: +1-(770)-565-6166 Fax: +1-(678)-894-8320 E-Mail:

12 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.

• 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.

• Catecholamines Chromatographic/Fluorometric Method Test (FDA Code: CHQ / 862.1165)

A catecholamines (total) test system is a device intended to determine whether a group of similar compounds (epinephrine, norepinephrine, and dopamine) are present in urine and plasma. Catecholamine determinations are used in the diagnosis and treatment of adrenal medulla and hypertensive disorders, and for catecholamine-secreting tumors (pheochromo-cytoma, neuroblastoma, ganglioneuroma, and retinoblastoma).

• Clinical Use Gel Liquid Chromatography (FDA Code: KZR / 862.2260)

A high pressure liquid chromatography system for clinical use is a device intended to separate one or more drugs or compounds from a solution by processing the mixture of compounds (solutes) through a column packed with materials of uniform size (stationary phase) under the influence of a high pressure liquid (mobile phase). Separation of the solutes occurs either by absorption, sieving, partition, or selective affinity.

• Glutathione Chromatographic (FDA Code: JLN / 862.1365)

A glutathione test system is a device intended to measure glutathione (the tripeptide of glycine, cysteine, and glutamic acid) in erythrocytes (red blood cells). Glutathione measurements are used in the diagnosis and treatment of certain drug-induced hemolytic (erythrocyte destroying) anemias due to an inherited enzyme deficiency.

• Hexane Extraction Vitamin A Trifluoroacetic Acid (FDA Code: JOA / 862.1805)

A vitamin A test system is a device intended to measure vitamin A in serum or plasma. Measurements obtained by this device are used in the diagnosis and treatment of vitamin A deficiency conditions, including night blindness, or skin, eye, or intestinal disorders.

• Liquid Chromatography Electrochemical Detector Test (FDA Code: LEQ / 862.2260)

• Nitrosonaphthol Test for 5-Hydroxyindole Acetic Acid Nitrous Acid (FDA Code: CDA / 862.1390)

A 5-hydroxyindole acetic acid/serotonin test system is a device intended to measure 5-hydroxyindole acetic acid/serotonin in urine. Measurements of 5-hydroxyindole acetic acid/serotonin are used in the diagnosis and treatment of carcinoid tumors of endocrine tissue.

• P-Nitroaniline/Vanillin Vanilmandelic Acid Diazo Test (FDA Code: CDF / 862.1795)

A vanilmandelic acid test system is a device intended to measure vanilmandelic acid in urine. Measurements of vanilmandelic acid obtained by this device are used in the diagnosis and treatment of neuroblastoma, pheochromocytoma, and certain hypertensive conditions.

• Porphyrins Fluorometric Measurement (FDA Code: JKJ / 862.1595)

A porphyrins test system is a device intended to measure porphyrins (compounds formed during the biosynthesis of heme, a constituent of hemoglobin, and related compounds) in urine and feces. Measurements obtained by this device are used in the diagnosis and treatment of lead poisoning, porphyrias (primarily inherited diseases associated with disturbed porphyrin metabolism), and other diseases characterized by alterations in the heme pathway.

• Secondary Calibrator (FDA Code: JIT / 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.)

• Tacrolimus Enzyme Immunoassay (FDA Code: MLM / 862.1678)

A tacrolimus test system is a device intended to quantitatively determine tacrolimus concentrations as an aid in the management of transplant patients receiving therapy with this drug. This generic type of device includes immunoassays and chromatographic assays for tacrolimus.