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510(k) Data Aggregation
K Number
K024339Device Name
COZART EIA OPIATES ORAL FLUID KIT
Manufacturer
COZART BIOSCIENCE LTD.
Date Cleared
2003-04-07
(101 days)
Product Code
DIG
Regulation Number
862.3240Why did this record match?
Product Code :
DIG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cozart EIA Opiates Oral Fluid Kit is intended for use in clinical and analytical laboratories when used in conjunction with the Cozart RapiScan Oral Fluid collection system. Using this collection system it provides qualitative screening results for Opiates in human oral fluid at a cutoff concentration of 10ng/ml. This is equal to 30ng/mL in undiluted oral fluid as the collection system involves a 1:3 dilution of the sample. This assay is for professional use only and provides only a preliminary analytical test result. Clinical consideration and professional judgement must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a more confirmed analytical result a more specific alternative chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS) is the preferred confirmatory method.
Device Description
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