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510(k) Data Aggregation
K Number
K123364Device Name
25OH VITAMIN D TOTAL ELISA TEST
Manufacturer
Date Cleared
2013-07-15
(256 days)
Product Code
Regulation Number
862.1825Why did this record match?
Applicant Name (Manufacturer) :
DIASOURCE IMMUNOASSAYS, S.A.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The DIAsource 25 OH Vitamin D Total ELISA is intended for the quantitative measurement of 25hydroxy vitamin D2 and D3 (25 OH-D2 and 25 OH-D3) in human serum. The results are to be used in conjunction with other clinical and laboratory findings to assess the Vitamin D status of a patient.
Device Description
The DIAsource 25 OH Vitamin D Total ELISA Test is an enzyme linked immunosorbent assay to detect total 250H Vitamin D (D2 and D3) present in human serum. During the first incubation at room temperature, 250H Vitamin D is dissociated from binding serum proteins to fix on binding sites of a specific monoclonal antibody. After washing, a fixed amount of 250H Vitamin D-labeled with biotin in presence of horseradish peroxidase (HRP) compete with unlabeled 250H Vitamin D2 and 250H vitamin D3 present on the binding sites of the specific monoclonal antibody. After another incubation at room temperature, the microtiterplate is washed to stop the competition reaction. A chromogenic solution (TMB) is added and then stopped with a Stop Solution after the last incubation period. The amount of substrate turnover is determined colorimetrically by measuring the absorbance which is inversely proportional to the total 250H Vitamin D concentration.
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