Ethyl Alcohol ETH

Primary DI
04015630991761
Brand
Ethyl Alcohol ETH
Company
Roche Diagnostics GmbH
Model
11776312190
Catalog number
11776312190
Published
2016-09-20
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
DMLNAD-NADH, SPECIFIC REAGENT FOR ALCOHOL ENZYME METHOD

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DMLNad-Nadh, Specific Reagent For Alcohol Enzyme MethodClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952839000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952839000BOEHRINGER MANNHEIM ETHYL ALCOHOL ASSAYBoehringer Mannheim Corp.1995-08-24DML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04015630991761PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04015630991761040156309917614015630991761

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, kit, enzyme spectrophotometryA collection of reagents and other associated materials intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen, using an enzyme spectrophotometry method. It is typically used to assess for alcohol intoxication and in the management of alcoholism.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
315028860
Device count
1
Lot or batch
true
Expiration date on label
true

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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00630414596112Atellica CH ETOHSiemens Healthcare Diagnostics Inc.DML2017-12-21
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00842768002038Syva® Emit® II Plus Ethyl Alcohol AssaySiemens Healthcare Diagnostics Inc.DML2016-09-24
00842768014413Syva® Emit® II Plus Ethyl Alcohol AssaySiemens Healthcare Diagnostics Inc.DML2016-09-24
00630414569277ADVIA® Chemistry ETOH_2 Ethanol_2 ReagentsSiemens Healthcare Diagnostics Inc.DML2016-09-24
04015630927678Ethanol Gen2Roche Diagnostics GmbHDML2016-09-20
04015630991778Ethyl Alcohol ETHRoche Diagnostics GmbHDML2016-09-20