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510(k) Data Aggregation
K Number
K982767Device Name
RAICHEM HDL-CHOLESTEROL DIRECT REAGENT, HDL-CHOLESTEROL CALIBRATOR
Manufacturer
Date Cleared
1998-09-21
(46 days)
Regulation Number
862.1150Why did this record match?
Applicant Name (Manufacturer) :
RAICHEM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Raichem HDL-Cholesterol Direct Reagent is intended for the quantitative determination of HDL-Cholesterol in serum or plasma. The Raichem HDL-Cholesterol Calibrator is intended to be used for the calibration of the Raichem HDL-Cholesterol Direct assay.
Device Description
The Raichem HDL-Cholesterol Direct test is based upon two sets of reaction sequences. In the first set of reactions Chylomicrons. VLDL selectively react with cholesterol esterase and are then eliminated from the reaction scheme. The addition of the second reagent causes the reaction of HDL-Cholesterol with cholesterol esterase and the subsequent production of color. The resultant increase in absorbance is directly proportional to the concentration of HDL-Cholesterol in the sample. The Raichem HDL-Cholesterol Calibrator is a serum calibrator used for the calibration of the Raichem HDL-Cholesterol Direct assay.
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