Ethyl Alcohol DAU Calibrator, Calibrator #2

Primary DI
B07602230
Brand
Ethyl Alcohol DAU Calibrator, Calibrator #2
Company
LIN-ZHI INTERNATIONAL, INC.
Model
0223
Catalog number
0223
Device description
5mL/bottle.Concentration: 100 mg/dL of Ethanol.
Published
2016-07-05
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
DNNCalibrators, Ethyl Alcohol

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DNNCalibrators, Ethyl AlcoholClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K032461000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032461000ETHYL ALCOHOL ENZYMATIC ASSAY, CATALOG #0220 & 0221Lin-Zhi International, Inc.2003-10-03DIC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B07602230PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, calibrator/controlA material(s) which is used to both establish known reference points and to verify the performance of an assay intended to be used for the qualitative and/or qualitative detection of ethyl alcohol (ETOH) in a clinical specimen.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
840839190
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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