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Device Description : For the quantitative determination of total protein concentration in serum.
Device Class : 2
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative determination of Uric Acid in serum. For in vitro diagnost For the quantitative determination of Uric Acid in serum. For in vitro diagnostic use only. The determination of uric acid in serum is most commonly performed for the diagnosis of gout. Increased uric acid levels are also found in leukemia, polycythemia, familial idiopathic hyperuricemia, and conditions associated with decreased renal function.
Device Class : 1
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determ The HDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of High Density Lipoprotein Cholesterol in human serum or plasma. The reagent can assist in the diagnosis and treatment of patients at risk for developing coronary heart disease.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determ The LDL-Cholesterol Reagent Set is intended for the in vitro quantitative determination of Low Density Lipoprotein Cholesterol in human serum or plasma. The reagents can assist in the diagnosis and treatment of patients at risk of developing coronary heart disease. Elevated LDL cholesterol is the primary target of cholesterol-lowering therapy.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. Th For the quantitative determination of Hemoglobin A1c (HbA1c) in human blood. The determination of HbA1c is most commonly performed for the evaluation of glycemic control in diabetes mellitus. HbA1c values provide an indication of glucose levels over the preceding 4-8 weeks. A higher HbA1c value indicates poorer glycemic control. For in vitro diagnostic use only.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For the quantitative determination of C-reactive protein in serum or plasma by l For the quantitative determination of C-reactive protein in serum or plasma by latex particle enhanced immunoturbidimetric assay. For in vitro diagnostic use only. C-reactive protein (CRP) is an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. As such, CRP is considered to be one of the most sensitive indicators of inflammation.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For use in the determination of total iron-binding capacity in serum on automate For use in the determination of total iron-binding capacity in serum on automated chemistry analyzers. For in vitro diagnostic use only. Total iron-binding capacity (TIBC) is the measure of the ability of serum proteins, principally transferrin, to bind iron. It is the maximum concentration of iron that the serum proteins can bind.Together with the total serum iron concentration, the TIBC is used in the diagnosis and treatment of iron deficiency anemia, other disorders of iron metabolism, and chronic inflammatory disorders. As an index of nutritional status, Serum TIBC is increased in iron deficiency, and decreased in anemia that is due to chronic disease.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : The Chemistry calibrator is for use as a calibrator of CDS clinical chemistry as The Chemistry calibrator is for use as a calibrator of CDS clinical chemistry assays. This calibrator material is well suited for automated and semi-automated analytical procedures. The Chemistry calibrator is a human based serum. The concentration of the calibrator components have been adjusted to ensure optimal calibration of the CDS methods on specified analyzers. The product consists of lyophilized human serum and a diluent for reconstitution. The human serum contains additives to provide the defined assay values. The concentrations of the calibrator components are lot-specific.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : The Chemistry Control Level I is to be used for monitoring the accuracy and prec The Chemistry Control Level I is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. For in vitro diagnostic use only. The quality control material is prepared from human serum with enzymes, nonprotein constituents, non-human protein, and bacteriostatic agents added.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : The Chemistry Control Level II is to be used for monitoring the accuracy and pre The Chemistry Control Level II is to be used for monitoring the accuracy and precision of clinical chemistry procedures. This control contains constituents commonly of interest in a general chemistry control, including common drugs and thyroids. For in vitro diagnostic use only. The quality control material is prepared from human serum with enzymes, nonprotein constituents, non-human protein, and bacteriostatic agents added. The constituents were adjusted to the levels listed in Expected Values.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No