Profile: Streck Labs, Inc focuses on the area of cell stabilization & preservation, flow cytometry controls & preservatives, chemistry controls, a sedimentation rate product line and quality control devices. We maintain the market of hematology controls through a combination of Streck label, private label and patent licenses. We develop and manufacture control products for the clinical laboratory. Our quality management system complies with the FDA quality system regulation & is in compliance with ISO 9001:2000, ISO 13485:2003 and SOR/98-282 certifications.

The company was founded in 1971, has revenues of USD 25-50 Million, has ~290 employees and is ISO 9001 certified.

FDA Registration Number: 1950302

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• Metallic Containing Fixative (FDA Code: LDX / 864.4010)

• Microbiology Kit

• Multi Analyte Control (FDA Code: JJY / 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.

• Neurology Instruments

• Non-Mercury Thermometers

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

• Oxygen

• Oxygen Regulators

• Oxygen Sensors

• Oxygen System

• Oxygen Tank

• Phlebotomy Needles & Tourniquets

• 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.

• Primary Calibrator (FDA Code: JIS / 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.)

• Publications

• Publications Service

• Pyrex Test Tubes

• 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.

• Red Cell Control (FDA Code: GJR / 864.8625)

• Red Cell Lysing Fluid (FDA Code: GGK / 864.8540) A red cell lysing reagent is a device used to lyse (destroy) red blood cells for hemoglobin determinations or aid in the counting of white blood cells.

• Rimmed Glass Test Tubes

• Sickle Cell Test (FDA Code: GHM / 864.7825) A sickle cell test is a device used to determine the sickle cell hemoglobin content of human blood to detect sickle cell trait or sickle cell diseases.

• Stain Sets & Solutions

• Stationary Oxygen System

• Sterile Specimen Mailer and Storage Container (FDA Code: KDT / 864.3250) A specimen transport and storage container, which may be empty or prefilled, is a device intended to contain biological specimens, body waste, or body exudate during storage and transport in order that the matter contained therein can be destroyed or used effectively for diagnostic examination. If prefilled, the device contains a fixative solution or other general purpose reagent to preserve the condition of a biological specimen added to the container. This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.

• Test Tubes

• Thermocouple Thermometers

• Thermometers

• Tourniquets

• Water-microbiology kit

• White Cell Control (FDA Code: GGL / 864.8625)

• White-Cell And Red-Cell Indices Control Mixture (FDA Code: GLQ / 864.8625)