R & D Systems, Inc.

Contact: Ralph Hogancamp - Regulatory Affairs Manager
Web: http://www.rndsystems.com
Address: 614 McKinley Place N.E., Minneapolis, Minnesota 55413-2647, USA
Phone: +1-(800)-343-7475 | Map/Directions >>

Profile: R & D Systems, Inc. manufactures reagents for the research and hematology markets. We also offer controls and calibrators for hematology analyzers. Our products include proteins, antibodies, assay kits, multiplex assay, flow cytometry, mRNA quantitation & cell selection kits, cell culture & stem sell reagents, primer pairs and supplemental research reagents. We provide linearity and survey materials & inter-laboratory quality control programs for hematology division. We offer various types of calibrators, which are CD-Cal, CBC-CAL plus, CBC-CAL plus for ADVIA(R) 70, tech-cal and NEK-Cal whole blood calibrator. The CD-Cal whole blood calibrator is ideal for WBC, RBC, Hb, MCV, Plt, and MPV & has 45-day closed vial stability with 7-day open vial stability features.

The company has revenues of USD 50-100 Million, has ~450 employees. NASDAQ:TECH (SEC Filings)

FDA Registration Number: 2182501

15 Products/Services (Click for related suppliers)

• 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.

• Beta-2-Microglobulin Immunological Test System (FDA Code: JZG / 866.5630)

Abeta -2-microglobulin immunological test system is a device that consists of the reagents used to measure by immunochemical techniquesbeta -2-microglobulin (a protein molecule) in serum, urine, and other body fluids. Measurement ofbeta -2-microglobulin aids in the diagnosis of active rheumatoid arthritis and kidney disease.

• Cell Indices Calibrator (FDA Code: KRX / 864.8150)

A calibrator for cell indices is a device that approximates whole blood or certain blood cells and that is used to set an instrument intended to measure mean cell volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC), or other cell indices. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.

• Differential Cell Counter (FDA Code: GKZ / 864.5220)

An automated differential cell counter is a device used to identify one or more of the formed elements of the blood. The device may also have the capability to flag, count, or classify immature or abnormal hematopoietic cells of the blood, bone marrow, or other body fluids. These devices may combine an electronic particle counting method, optical method, or a flow cytometric method utilizing monoclonal CD (cluster designation) markers. The device includes accessory CD markers.

• Erythropoietin Assay (FDA Code: GGT / 864.7250)

A erythropoietin assay is a device that measures the concentration of erythropoietin (an enzyme that regulates the production of red blood cells) in serum or urine. This assay provides diagnostic information for the evaluation of erythrocytosis (increased total red cell mass) and anemia.

• Hematology Quality Control Mixture (FDA Code: JPK / 864.8625)

A hematology quality control mixture is a device used to ascertain the accuracy and precision of manual, semiautomated, and automated determinations of cell parameters such as white cell count (WBC), red cell count (RBC), platelet count (PLT), hemoglobin, hematocrit (HCT), mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC).

• Hemoglobin and Hematocrit Measurement Calibrator (FDA Code: KRZ / 864.8165)

A calibrator for hemoglobin or hematocrit measurement is a device that approximates whole blood, red blood cells, or a hemoglobin derivative and that is used to set instruments intended to measure hemoglobin, the hematocrit, or both. It is a material whose characteristics have been precisely and accurately determined.

• Hemoglobin Control (FDA Code: GGM / 864.8625)

• Laboratory Reagent

• Microplate

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

• Normal and Abnormal Cell Counter Control (FDA Code: JCN / 864.8625)

• Platelet Counting Calibrator (FDA Code: KRY / 864.8175)

A calibrator for platelet counting is a device that resembles platelets in plasma or whole blood and that is used to set a platelet counting instrument. It is a suspension of particles or cells whose size, shape concentration, and other characteristics have been precisely and accurately determined.

• Red and White Cell Counting Calibrator (FDA Code: KSA / 864.8185)

A calibrator for red cell and white cell counting is a device that resembles red or white blood cells and that is used to set instruments intended to count red cells, white cells, or both. It is a suspension of particles or cells whose size, shape, concentration, and other characteristics have been precisely and accurately determined.

• Transferrin Immunochemical (FDA Code: JNM / 866.5880)

A transferrin immunological test system is a device that consists of the reagents used to measure by immunochemical techniques the transferrin (an iron-binding and transporting serum protein) in serum, plasma, and other body fluids. Measurement of transferrin levels aids in the diagnosis of malnutrition, acute inflammation, infection, and red blood cell disorders, such as iron deficiency anemia.