FDA.reportPublic FDA data

EtOH CAL/CONTROL

Primary DI
05055273207873
Brand
EtOH CAL/CONTROL
Company
RANDOX LABORATORIES LIMITED
Model
DA2703
Catalog number
DA2703
Device description
The Randox Ethanol Calibrator and Control Set is intended for the calibration and quality control of the Randox Ethanol assay, which is used for the quantitative analysis of ethanol in human urine and serum.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DLJCalibrators, Drug Specific
LASDrug Specific Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DLJCalibrators, Drug SpecificClinical Toxicology2
LASDrug Specific Control MaterialsClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092273000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092273000RANDOX ETHANOL ASSAYRandox Laboratories, Ltd.2010-11-01DIC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273207873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273207873050552732078735055273207873

GMDN Terms#

Term, Definition table
TermDefinition
Ethanol (ETOH) IVD, controlA material which is used to verify the performance of an assay intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00The Ethanol Calibrators and Controls are stable for 28 days at +2°C to +8°C.
Storage Environment Temperature2 Degrees Celsius8 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+442894451070technical.services@randox.com

Regulatory Flags#

DUNS number
227530649
Device count
1
Kit
true
Lot or batch
true
Expiration date on label
true

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