The ethanol assay is an in vitro diagnostic test for the quantitative analysis of ethanol in human urine and serum.

The ethanol assay is an in vitro diagnostic test for the quantitative analysis of ethanol in human urine and serum.
EtOH - DA4015

Device Description

A substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.

Environmental Conditions

Special Storage Condition, Specify

Avoid prolonged exposure of the reagent at temperatures higher than +25ºC

Storage Environment Temperature - Degrees Celsius

8.00
2.00

Device Sizes

No Data Available

Device Sterilization

Device Sterile: False

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: DIC

Device Name: Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Device Class: 2

Physical State: N/A

Definition: N/A

Submission Type ID: 1

Review Panel: TX

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: N/A

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: N/A

Regulation Number: 862.3040

Third Party Flag: Y

Medical Specialty: TX

Device Identifiers

Device Id: 05055273208085

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A