FDA.reportPublic FDA data

DOA CAL

Primary DI
05055273202458
Brand
DOA CAL
Company
RANDOX LABORATORIES LIMITED
Model
EV3550
Catalog number
EV3550
Device description
Evidence® Drugs of Abuse Calibrators are intended for in vitro diagnostic use in the calibration of the Randox Drugs of Abuse Panel on the Evidence® analyser.
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
DKBCalibrators, Drug Mixture

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DKBCalibrators, Drug MixtureClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030360000
K040350000
K040570000
K041142000
K041143000
K041144000
K043071000
K050179000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030360000RANDOX EVIDENCERandox Laboratories, Ltd.2003-12-23DIO
K040350000RANDOX AMPHETAMINE CLASS ASSAYRandox Laboratories, Ltd.2004-05-12DKZ
K040570000RANDOX METHADONE ASSAYRandox Laboratories, Ltd.2004-05-10DJR
K041142000RANDOX CANNABINOIDS ASSSAYRandox Laboratories, Ltd.2004-11-23LDJ
K041143000RANDOX BARBITURATE ASSAYRandox Laboratories, Ltd.2004-11-05DIS
K041144000RANDOX OPIATES ASSAYRandox Laboratories, Ltd.2004-11-03DJG
K043071000RANDOX PHENCYCLIDINE ASSAYRandox Laboratories, Ltd.2005-01-27LCM
K050179000RANDOX BENZODIAZEPINE CLASS ASSAYRandox Laboratories, Ltd.2005-05-17JXM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273202458PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273202458050552732024585055273202458

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, calibratorA material which is used to establish known points of reference for an assay intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen.

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
+442894422413technical.services@randox.com

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
05055273200034ALBAB3800AB38002016-09-16
05055273200041ALBAB362AB3622016-09-16
05055273200058ALBAB3800AB38002016-09-16
05055273208115ALBAB8301AB83012016-09-16
05055273218985ConcizuTrace™ ELISACZM10591CZM105912025-05-30
05055273203400GLUTATHIONE REDUCTASE (GLUT RED)GR23682019-06-03
05055273203417GLUTATHIONE REDUCTASE CONTROL SERUM (GLUT RED CONTROL)GR26082019-06-03
05055273203424GLUTATHIONE REDUCTASE CALIBRATION SERUM (GLUT RED CAL)GR26092019-06-03
05055273205091RABSRP3857RP38572016-09-26
05055273205893RX daytonaRX3900RX39002018-06-07

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00613647025291FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.DKB2023-06-20
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00811727017574Pointe Multi-Analyte Set C Urine DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017581Pointe Multi-Analyte Set C Urine DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017611Pointe Multi-Analyte Set D Urine DAU Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
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00811727017635Pointe Multi-Analyte Set D Urine DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
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00811727017659Pointe Multi-Analyte Set D Urine DAU High CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017680Pointe Multi-Analyte E DAU Negative CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017697Pointe Multi-Analyte E DAU Low CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017703Pointe Multi-Analyte E DAU Cutoff CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
00811727017710Pointe Multi-Analyte E DAU Intermediate CalibratorHORIBA INSTRUMENTS INCORPORATEDDKB2020-09-25
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