FDA.reportPublic FDA data

BZG

Primary DI
05055273208047
Brand
BZG
Company
RANDOX LABORATORIES LIMITED
Model
DA4011
Catalog number
DA4011
Device description
The Cocaine assay is an in vitro diagnostic test for the qualitative and semi-quantitative detection of benzoylecgonine (Cocaine Metabolite) in human urine.
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
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K113751000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K113751000RANDOX COCAINE METABOLITERandox Laboratories, Ltd.2012-05-08DIO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273208047PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273208047050552732080475055273208047

GMDN Terms#

Term, Definition table
TermDefinition
Cocaine/cocaine metabolite IVD, reagentA substance or reactant intended to be used together with a parent IVD to perform a specific function in an assay that is used for the qualitative and/or quantitative detection of cocaine and/or cocaine metabolites in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Once opened the reagent is stable on board the analyser for 28 days at approximately +10°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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Primary DI, Brand, Model table
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05055273200560AMYAY1580AY15802016-09-09
05055273200577AMYAY1582AY15822016-09-09
05055273200584AMYAY2811AY28112016-09-09
05055273200591P AMYAY2862AY28622016-09-09
05055273200607AMYAY3805AY38052016-09-09
05055273200614P AMYAY3855AY38552016-09-09
05055273200645AMYAY7931AY79312016-09-09
05055273200652AMYAY7932AY79322016-09-09
05055273200669P AMYAY7934AY79342016-09-09
05055273200676AMYAY9707AY97072016-09-09
05055273220780BIOHACKER Premium Home Blood Sampling Collection KitSCK10754SCK107542026-05-22
05055273220797MALE HORMONE Premium Home Blood Sampling Collection KitSCK10755SCK107552026-05-22
05055273220803BASELINE Venous Sample Collection kitSCK10756SCK107562026-05-22
05055273220995FEMALE HORMONE Premium Home Blood Sampling Collection KitSCK10767SCK107672026-05-22
05055273221640BASELINE SELF-DRAW Premium Home Blood Sampling Collection KitSCK10796SCK107962026-05-22
05055273207620COAGULATION CONTROL - LEVEL 1 (COAG CONTROL 1)CG50212019-06-03
05055273207637COAGULATION CONTROL - LEVEL 2 (COAG CONTROL 2)CG50222019-06-03
05055273207644COAGULATION CONTROL - LEVEL 3 (COAG CONTROL 3)CG50232019-06-03
05055273208405COAGULATION CALIBRATOR (COAG CAL)CG50372019-06-03
05055273204476APOLIPOPROTEIN E (APO E)LP38642019-06-03

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