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Device Description : The CRP Calibrator Set is intended to be used for the calibration of the CDS CRP The CRP Calibrator Set is intended to be used for the calibration of the CDS CRP Reagents. For in vitro diagnostic use only. The calibrators in this kit contain known quantities of human C-reactive protein. These reagents are to be used as calibrators with the manufacturer’s CRP Reagents.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : These CRP Controls Set are intended for use in CRP test systems to validate perf These CRP Controls Set are intended for use in CRP test systems to validate performance of the assay. The controls may also be useful in assessing test precision or analytical errors.2 For in vitro diagnostic use only. C-reactive protein (CRP) is described in the literature as an acute phase protein that is involved in the activation of complement, acceleration of phagocytosis, and detoxification of substances released from damaged tissue. CRP is one of the most sensitive indicators of inflammation.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : This product is for the purpose of monitoring accuracy and precision in the quan This product is for the purpose of monitoring accuracy and precision in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only. Throughout the circulatory life of the red cell, Hemoglobin A1c is formed continuously by the adduction of glucose to the N-terminal of the hemoglobin beta chain. This process, which is non-enzymatic, reflects the average exposure of hemoglobin to glucose over an extended period.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay For calibrating the quantitative Direct Total Iron-Binding Capacity (TIBC) assay on automated chemistry analyzer systems. Using the Direct TIBC reagents, measurement of the total iron-binding capacity of serum occurs in a fully automated manner, without the need for any off-line separation. Since the entire reaction process is monitored by the chemistry analyzer, it is necessary to calibrate the assay with serum-based calibrators which are carried through the same reaction process as the patient specimens.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : This product is intended for in-vitro use in the quality control of HDL, LDL, Ap This product is intended for in-vitro use in the quality control of HDL, LDL, Apolipoprotein A-1, Apolipoprotein B, and Lipopro-tein (a) methods on clinical chemistry systems. The Multi-Analyte Lipid Control Set is a set of three serum levels. These three levels are to be used exclusively with the CDS HDL Cholesterol Reagent, CDS LDL Cholesterol Reagent, (CDS 501-419 and CDS 501-420) which are assays for the quan-tification of various lipids and lipoproteins in human serum.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No
Device Description : This product is for the purpose of calibrating results in the quantitative deter This product is for the purpose of calibrating results in the quantitative determination of human hemoglobin A1c (HbA1c) in blood by automated immunoassay. For in vitro diagnostic use only.
Device Class :
Duns Number: 048144997
Premarket Exempt : No
Prescription Use : No