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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• Accreditation, Cd-roms

• 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.

• Automated Sedimentation Rate Device (FDA Code: GKB / 864.5800) An automated sedimentation rate device is an instrument that measures automatically the erythrocyte sedimentation rate in whole blood. Because an increased sedimentation rate indicates tissue damage or inflammation, the erythrocyte sedimentation rate device is useful in monitoring treatment of a disease.

• Blood Bank Test Kits

• Blood Cell Diluent (FDA Code: GIF / 864.8200) A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.

• Blood Collection Systems (FDA Code: JKA / 862.1675) A blood specimen collection device is a device intended for medical purposes to collect and to handle blood specimens and to separate serum from nonserum (cellular) components prior to further testing. This generic type device may include blood collection tubes, vials, systems, serum separators, blood collection trays, or vacuum sample tubes.

• Breathing Oxygen

• Calibrators

• Calibrators for Equipment

• Cardiopulmonary Systems, Hollow Fiber Oxygenator

• Cardiopulmonary Systems, Oxygenator

• 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.

• Clinical Diagnostic Solutions, Hematology Reagents

• Clinical Mercury Thermometers (FDA Code: FLK / 880.2920) A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.

• Compliance Resources, Clinical Lab

• Compliance Service, FDA

• Controls

• Controls for Diagnostic Equipment

• Cytology Test Kits

• Diabetic Monitoring

• Digital Thermometers

• Digoxin Calibrators

• Drying Unit (FDA Code: JRJ / 862.2050) General purpose laboratory equipment labeled or promoted for a specific medical use is a device that is intended to prepare or examine specimens from the human body and that is labeled or promoted for a specific medical use.

• Ear Thermometers

• Erythrocyte Sedimentation Rate Test (FDA Code: JPH / 864.6700) An erythrocyte sedimentation rate test is a device that measures the length of time required for the red cells in a blood sample to fall a specified distance or a device that measures the degree of sedimentation taking place in a given length of time. An increased rate indicates tissue damage or inflammation.

• Flow Cytometry

• Flow Cytometry Test Kits

• Forehead Thermometers

• General Chemistry Calibrators

• General Chemistry Test Kits

• General Diagnostic Supplies

• General Diagnostics

• General Examination Supplies

• General Medical Supplies

• Giant Test Tubes

• Hematology Controls Cbc

• Hematology Instruments

• Hematology Kits

• 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).

• Hematology Reagents

• Hematology Reagents and Kits

• Hematology Reagents and Kits Hemoglobin A1C (Glycohemoglobin)

• Hematology Reagents and Supplies

• Hematology Reticulocyte Controls

• Hematology Sedimentation Controls

• 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.

• Ice Bath

• Lab Automation Systems

• Liquid Oxygen Systems

• Medical Oxygen