Syva® Emit® II Plus Ethyl Alcohol Assay

Primary DI
00842768002021
Brand
Syva® Emit® II Plus Ethyl Alcohol Assay
Company
Siemens Healthcare Diagnostics Inc.
Model
10445452
Catalog number
9K309UL
Device description
Syva® Emit® II Plus Ethyl Alcohol Assay - 115 mL Kit
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K993980000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K993980000SYVA EMIT II PLUS ETHYL ALCOHOL ASSAY, MODELS 9K309UL/9K409ULSyva Co.2000-02-01DML

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842768002021PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842768002021008427680020218427680020210842768002021

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

Contacts#

Phone, Email table
PhoneEmail
+1(800)227-8994XX@XX.XX
+1(800)227-8994CONTACT@SIEMENS-HEALTHINEERS.COM

Regulatory Flags#

DUNS number
005088112
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
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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
04015630991761Ethyl Alcohol ETHRoche Diagnostics GmbHDML2016-09-20
04015630991778Ethyl Alcohol ETHRoche Diagnostics GmbHDML2016-09-20