5-Anhydroglucitol (15ag) 1 Assay,Abnormal Hemoglobin Control Suppliers & Manufacturers

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5-Anhydroglucitol (15ag) 1 Assay (FDA Code: NOZ / 864.747)

Identification. A glycosylated hemoglobin assay is a device used to measure the glycosylated hemoglobins (A1a, A1b, and A1c) in a patient's blood by a column chromatographic procedure. Measurement of glycosylated hemoglobin is used to assess the level of control of a patient's diabetes and to determine the proper insulin dosage for a patient. Elevated levels of glycosylated hemoglobin indicate uncontrolled diabetes in a patient.

Classification. Class II (performance standards).

Takasaki Plant, Nippon Kayaku Co., Ltd.

Abnormal Hemoglobin Control (FDA Code: JCM / 864.7415)
Bio-Rad Laboratories, Inc., Nichols Institute Diagnostics, Perkinelmer, Inc., more...

Abnormal Hemoglobin Quantitation Test (FDA Code: GKA / 864.7415)

Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.

Classification. Class II (performance standards).

Bio-Rad Laboratories, Inc., PerkinElmer, Inc.(LAS), Perkinelmer, Inc., more...

Abnormal Hemoglobin Variant (FDA Code: MLL / 864.7415)

Identification. An abnormal hemoglobin assay is a device consisting of the reagents, apparatus, instrumentation, and controls necessary to isolate and identify abnormal genetically determined hemoglobin types.

Classification. Class II (performance standards).

Sebia Electrophoresis

Abnormal Plasma Control (FDA Code: GGC / 864.5425)

Identification. A multipurpose system for in vitro coagulation studies is a device consisting of one automated or semiautomated instrument and its associated reagents and controls. The system is used to perform a series of coagulation studies and coagulation factor assays.

Classification. Class II (performance standards).

Corgenix, Inc., Medtronic Xomed Surgical Products, Inc, Siemens Healthcare Diagnostics, more...

ABO Blood Grouping Antiserum
Siemens Healthcare Diagnostics, Medtro Gmbh, Atlas Laboratories Co. Ltd., more...

Acid Hematin (FDA Code: GGF / 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).

AVL Medical Instruments (Japan), Roche Diagnostics Gmbh

Acquired Immune Deficiency Syndrome (AIDS) Antibody Test
ACON Laboratories, Inc., Home Access Health Corporation, Akers Biosciences, Inc., more...

Activated Partial Thromboplastin (FDA Code: GFO / 864.7925)

Identification. A partial thromboplastin time test is a device used for primary screening for coagulation abnormalities, for evaluation of the effect of therapy on procoagulant disorders, and as an assay for coagulation factor deficiencies of the intrinsic coagulation pathway.

Classification. Class II (performance standards).

Teco Diagnostics, Siemens Healthcare Diagnostics, Remel, more...

Activated Whole Blood Clotting Time (FDA Code: JBP / 864.714)

Identification. An activated whole blood clotting time tests is a device, used to monitor heparin therapy for the treatment of venous thrombosis or pulmonary embolism by measuring the coagulation time of whole blood.

Classification. Class II (performance standards).

Medtronic Xomed Surgical Products, Inc, Medtronic, Inc., International Technidyne Corp., more...

Alkali Resistant Hemoglobin (FDA Code: GHA / 864.7455)

Identification. A fetal hemoglobin assay is a device that is used to determine the presence and distribution of fetal hemoglobin (hemoglobin F) in red cells or to measure the amount of fetal hemoglobin present. The assay may be used to detect fetal red cells in the maternal circulation or to detect the elevated levels of fetal hemoglobin exhibited in cases of hemoglobin abnormalities such as thalassemia (a hereditary hemolytic anemia characterized by a decreased synthesis of one or more types of hemoglobin polypeptide chains). The hemoglobin determination may be made by methods such as electrophoresis, alkali denaturation, column chromatography, or radial immunodiffusion.

Classification. Class II (performance standards).

Analytical Control Systems, Inc.

Antithrombin III Quantitation Test (FDA Code: JBQ / 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).

Teco Diagnostics, Siemens Healthcare Diagnostics, Instrumentation Laboratory (IL), more...

Apheresis Equipment
Medtronic, Inc., Fenwal Inc., Biomerieux Industry, more...

Automated Blood Cell Diluting Apparatus (FDA Code: GKH / 864.524)

Identification. An automated blood cell diluting apparatus is a fully automated or semi-automated device used to make appropriate dilutions of a blood sample for further testing.

Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 864.9.

Becton, Dickson & Co.,, Beckman Coulter, Inc., Veridex, LLC, more...

Automated Blood Grouping and Antibody Test System (FDA Code: KSZ / 864.9175)

Identification. An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.

Classification. Class II (performance standards).

Olympus America, Inc., Carolina Biological Supply Company, Beckman Coulter, Inc., more...

Automated Cell Counter (FDA Code: GKL / 864.52)

Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

Classification. Class II (performance standards).

Iris Diagnostics, Siemens Healthcare Diagnostics, Sysmex America, Inc., more...

Automated Cell-Locating Device (FDA Code: JOY / 864.526)

Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)

Classification. Class II (performance standards).

Carl Zeiss Microimaging Ais, Inc, Dako North America, Inc., Applied Imaging Corp., more...

Automated Clot Timer (FDA Code: GKN / 864.54)

Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

Classification. Class II (performance standards).

Medtronic Xomed Surgical Products, Inc, International Technidyne Corp., Heller Laboratories

Automated Coagulation Instrument (FDA Code: GKP / 864.54)

Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

Classification. Class II (performance standards).

Siemens Healthcare Diagnostics, Sysmex America, Inc., Remel, more...

Automated Coagulation Timer
Instrumentation Laboratory (IL), Quest Medical, Inc., Medical Sales & Service

Automated Combs Test System (FDA Code: KSM / 864.93)

Identification. An automated Coombs test system is a device used to detect and identify antibodies in patient sera or antibodies bound to red cells. The Coombs test is used for the diagnosis of hemolytic disease of the newborn, and autoimmune hemolytic anemia. The test is also used in crossmatching and in investigating transfusion reactions and drug-induced red cell sensitization.

Classification. Class II (performance standards).

Medion Diagnostics Ag

Automated Hematocrit Instrument (FDA Code: GKF / 864.56)

Identification. An automated hematocrit instrument is a fully automated or semi-automated device which may or may not be part of a larger system. This device measures the packed red cell volume of a blood sample to distinguish normal from abnormal states, such as anemia and erythrocytosis (an increase in the number of red cells).

Classification. Class II (performance standards).

Siemens Healthcare Diagnostics, Remel, Instrumentation Laboratory (IL), more...

Automated Hematology Slide Stainer
Siemens Healthcare Diagnostics, Wescor Inc., Global Medical Instrumentation, Inc., more...

Automated Hemoglobin System (FDA Code: GKR / 864.562)

Identification. An automated hemoglobin system is a fully automated or semi-automated device which may or may not be part of a larger system. The generic type of device consists of the reagents, calibrators, controls, and instrumentation used to determine the hemoglobin content of human blood.

Classification. Class II (performance standards).

Osmetech, Inc., Siemens Healthcare Diagnostics, Instrumentation Laboratory (IL), more...

Automated Heparin Analyzer (FDA Code: JOX / 864.568)

Identification. An automated heparin analyzer is a device used to determine the heparin level in a blood sample by mixing the sample with protamine (a heparin-neutralizing substance) and determining photometrically the onset of air-activated clotting. The analyzer also determines the amount of protamine necessary to neutralize the heparin in the patient's circulation.

Classification. Class II (special controls).

Medtronic Xomed Surgical Products, Inc, Medtronic, Inc.

Automated Intelligent Microscope
ChromoDynamics, Inc., Leica Microsystems GmbH, Nikon Canada Inc., Instrument Div.

Automated Occult Blood Analyzer (FDA Code: OOX / 864.655)

Identification. An occult blood test is a device used to detect occult blood in urine or feces. (Occult blood is blood present in such small quantities that it can be detected only by chemical tests of suspected material, or by microscopic or spectroscopic examination.)

Classification. Class II (performance standards).

Eiken Chemical Co., Inc.

Automated Platelet Aggregation System (FDA Code: JOZ / 864.57)
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 platelet-rich plasma.

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).

Accumetrics, Siemens Healthcare Diagnostics, Medimpex United, Inc., more...

Automated Platelet Counter (FDA Code: GKX / 864.52)

Identification. An automated cell counter is a fully-automated or semi-automated device used to count red blood cells, white blood cells, or blood platelets using a sample of the patient's peripheral blood (blood circulating in one of the body's extremities, such as the arm). These devices may also measure hemoglobin or hematocrit and may also calculate or measure one or more of the red cell indices (the erythrocyte mean corpuscular volume, the mean corpuscular hemoglobin, or the mean corpuscular hemoglobin concentration). These devices may use either an electronic particle counting method or an optical counting method.

Classification. Class II (performance standards).

Siemens Healthcare Diagnostics, Beckman Coulter, Inc.

Automated Sedimentation Rate Device (FDA Code: GKB / 864.58)

Identification. 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.

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.

Beckman Coulter, Inc., Streck Labs, Inc, Airscan, Inc., more...

Automated Slide Spinner (FDA Code: GKJ / 864.585)

Identification. An automated slide spinner is a device that prepares automatically a blood film on a microscope slide using a small amount of peripheral blood (blood circulating in one of the body's extremities, such as the arm).

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.

Iris Diagnostics, Iris Sample Processing, Beckman Coulter, Inc., more...

Autotransfusion Blood Bags
Cook Surgical, Inc., Millipore, Atrium Medical Corporation, more...

B And T Lymphocyte Dna-Probe (FDA Code: MAM / 864.522)
Invivoscribe Technologies, Inc.

B Lymphocyte Marker Assay (FDA Code: LJD / 864.522)
Becton, Dickson & Co.,, The Binding Site, Gen Trak, Inc.

Bleeding Time Device (FDA Code: JCA / 864.61)

Identification. A bleeding time device is a device, usually employing two spring-loaded blades, that produces two small incisions in the patient's skin. The length of time required for the bleeding to stop is a measure of the effectiveness of the coagulation system, primarily the platelets.

Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to 864.9.

Medtronic, Inc., International Technidyne Corp., Biomerieux Industry, more...

Blood & Components Collection Container (FDA Code: KSR / 864.91)

Identification. An empty container for the collection and processing of blood and blood components is a device intended for medical purposes that is an empty plastic bag or plastic or glass bottle used to collect, store, or transfer blood and blood components for further processing.

Classification. Class II (performance standards).

Autosuture, Haemonetics Corporation, Medtronic, Inc., more...

Blood and Plasma Warming Device (FDA Code: KZL / 864.9205)

Identification. A nonelectromagnetic blood and plasma warming device is a device that warms blood or plasma, by means other than electromagnetic radiation, prior to administration.

Classification. Class II (performance standards).

Autosuture, Arizant Healthcare Inc., Trivirix, more...

Blood Antibody Potentiator
Siemens Healthcare Diagnostics, Medion Diagnostics Ag

Blood Bag
Millipore, Atrium Medical Corporation, Integra Biotechnical LLC, more...

Blood Bag Spikes
Millipore, Atrium Medical Corporation, Utah Medical Products, Inc., more...

Blood Bag Tube Sealer
Millipore, Atrium Medical Corporation, SEBRA, more...

Blood Bank Software (FDA Code: MMH / 864.9175)

Identification. An automated blood grouping and antibody test system is a device used to group erythrocytes (red blood cells) and to detect antibodies to blood group antigens.

Classification. Class II (performance standards).

Roche Molecular Systems, Inc, Wyndgate Technologies, Gen-probe Incorporated, more...

Blood Bank Supplies (FDA Code: KSS / 864.905)

Identification. Blood bank supplies are general purpose devices intended for in vitro use in blood banking. This generic type of device includes products such as blood bank pipettes, blood grouping slides, blood typing tubes, blood typing racks, and cold packs for antisera reagents. The device does not include articles that are licensed by the Center for Biologics Evaluation and Research of the Food and Drug Administration.

Classification. Class I (general controls).

Arthrex, Inc., Biomet, Inc, Thermo Fisher Scientific Inc, more...

Blood Cell Diluent (FDA Code: GIF / 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.

Iris Diagnostics, Bio-Rad Laboratories, Inc., Siemens Healthcare Diagnostics, more...

Blood Cell Identification Panel
Siemens Healthcare Diagnostics, Zhejiang Bestrest Health Care Equipment Co., Ltd.

Blood Circulating Epithelial Cancer Cell Control Material (FDA Code: NRS / 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).

Veridex, LLC, Alcan Packaging-Bethlehem

Blood Clot Coagulation Analyzer (FDA Code: GKP / 864.54)

Identification. A coagulation instrument is an automated or semiautomated device used to determine the onset of clot formation for in vitro coagulation studies.

Classification. Class II (performance standards).

Siemens Healthcare Diagnostics, Sysmex America, Inc., Remel, more...

Blood Collection Tray (FDA Code: GJE / 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.

Siemens Healthcare Diagnostics, Heathrow Scientificr LLC, Healthmark Industries Co., more...

Blood Diluting Pipettes
Siemens Healthcare Diagnostics, Cole-Parmer Instrument Company, Corning Incorporated, more...

Blood Donor Kit
The Metrix Co., Open Trade, S.A.

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