Thromboplastin Generation Test,Two Stage Clotting Time Assay for Antithrombin III Suppliers & Manufacturers
Identification. A thromboplastin generation test is a device used to detect and identify coagulation factor deficiencies and coagulation inhibitors.
Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.
Two Stage Clotting Time Assay for Antithrombin III (FDA Code: JPE / 864.706)
Identification. An antithrombin III assay is a device that is used to determine the plasma level of antithrombin III (a substance which acts with the anticoagulant heparin to prevent coagulation). This determination is used to monitor the administration of heparin in the treatment of thrombosis. The determination may also be used in the diagnosis of thrombophilia (a congenital deficiency of antithrombin III).
Classification. Class II (performance standards).
Urinary 11-Dehydro Thromboxane B2 Kit (FDA Code: OBW / 864.57)
Identification. An automated platelet aggregation system is a device used to determine changes in platelet shape and platelet aggregation following the addition of an aggregating reagent to a platelet-rich plasma.
Classification. Class II (performance standards).
Urine Leukocyte Test (FDA Code: LJX / 864.7675)
Identification. 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.
Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.
Vacuum Sample Tube with Anticoagulant (FDA Code: GIM / 862.1675)
Identification. 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.
Classification. Class II.
Viewer/Magnifier
Eschenbach Optik of America Inc., Fisher Scientific International, Inc., Image Marketing Corp., more...
Vitamin K Epoxide Reductase Complex Subunit One (Vkorc1) Genotyping System (FDA Code: ODV / 864.775)
Identification. A prothrombin time test is a device used as a general screening procedure for the detection of possible clotting factor deficiencies in the extrinsic coagulation pathway, which involves the reaction between coagulation factors III and VII, and to monitor patients receiving coumarin therapy (the administration of one of the coumarin anticoagulants in the treatment of venous thrombosis or pulmonary embolism).
Classification. Class II (performance standards).
Water Bath Blood Warmer
Smiths Medical ASD, Inc
White Cell Control (FDA Code: GGL / 864.8625)
Identification. 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).
Classification. Class II (performance standards).
White Cell Diluting Fluid (FDA Code: GGJ / 864.82)
Identification. A blood cell diluent is a device used to dilute blood for further testing, such as blood cell counting.
Classification. Class I (general controls). This device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in 864.9.
White-Cell And Red-Cell Indices Control Mixture (FDA Code: GLQ / 864.8625)
Identification. 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).
Classification. Class II (performance standards).
Whole Blood Coagulation Analyzer
Instrumentation Laboratory (IL), Biomerieux Industry, Roche Diagnostics.
Whole Blood Hemoglobin Determination Test (FDA Code: KHG / 864.75)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.
Classification. Class II (performance standards).
Whole Blood Oximeter (FDA Code: GLY / 864.75)
Identification. A whole blood hemoglobin assay is a device consisting or reagents, calibrators, controls, or photometric or spectrophotometric instrumentation used to measure the hemoglobin content of whole blood for the detection of anemia. This generic device category does not include automated hemoglobin systems.
Classification. Class II (performance standards).
