AIMSTRIP ALCOHOL SALIVA

Primary DI
00695684400705
Brand
AIMSTRIP ALCOHOL SALIVA
Company
GERMAINE LABORATORIES, INC
Model
40070
Device description
Semi-quantitative test for blood alcohol concentration
Published
2016-05-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DICAlcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme MethodClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00695684400705PrimaryGS10
00695684400701Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00695684400705006956844007056956844007050695684400705
00695684400701006956844007016956844007010695684400701

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, kit, colorimetric, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of ethyl alcohol (ETOH) in a clinical specimen within a short period, relative to standard laboratory testing procedures, using a colorimetric method. This test is commonly used in the laboratory or in point-of-care analyses to assess for alcohol intoxication and in the management of alcoholism.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
176458115
Device count
30
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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