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510(k) Data Aggregation
K Number
K013538Device Name
ETHANOL
Manufacturer
ABBOTT LABORATORIES
Date Cleared
2001-12-14
(51 days)
Product Code
DML
Regulation Number
862.3040Why did this record match?
Product Code :
DML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ethanol assay is used for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The Ethanol assay should be exclusively used to detect ethanol and not other alcohols such as isopropanol or methanol. Reactivity with compounds structurally unrelated to ethanol has not been observed.
Device Description
Ethanol is an in vitro diagnostic assay for the quantitative analysis of ethyl alcohol (ethanol) in human serum, plasma, or urine. The assay is based on an enzymatic reaction. Active enzyme converts NAD to NADH, resulting in an absorbance change that can be measured spectrophotometrically. The increase in absorbance at 340 nm is proportional to the concentration of alcohol in the specimen.
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K Number
K993980Device Name
SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409UL
Manufacturer
SYVA CO.
Date Cleared
2000-02-01
(69 days)
Product Code
DML
Regulation Number
862.3040Why did this record match?
Product Code :
DML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative analysis of ethyl alcohol in human serum or plasma.
The Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in the quantitative analysis of ethyl alcohol in human urine, plasma, and serum. The Emit® II Plus Ethyl Alcohol Assay is designed for use with most clinical chemistry analyzers.
Device Description
The Syva Emit® II Plus Ethyl Alcohol Assay is an enzyme assay intended for use in quantitative analysis of ethyl alcohol in human urine, serum, or plasma.
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K Number
K963197Device Name
ON.SITE ALCOHOL
Manufacturer
ANSYS, INC.
Date Cleared
1996-09-19
(35 days)
Product Code
DML
Regulation Number
862.3040Why did this record match?
Product Code :
DML
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
ON•SITE Alcohol is recommended for professional use only and is not intended for overthe-counter sale to the general public. Professional use includes applications in healthcare, corrections and drug treatment.
ON•SITE Alcohol yields only a "qualitative" result. A positive result indicates that alcohol (ethanol) is present at a concentration of approximately 0.02% when performed according to the instructions.
Confirmation of ON•SITE Alcohol results using gas chromatography is recommended if quantitative results are desired.
Device Description
ON•SITE Alcohol is a self contained, disposable enzymatic test device that provides rapid detection of alcohol in saliva or urine. It includes all reagents and supplies necessary to perform the test.
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