FDA.reportPublic FDA data

DOA CAL

Primary DI
05055273207880
Brand
DOA CAL
Company
RANDOX LABORATORIES LIMITED
Model
DA2704
Catalog number
DA2704
Device description
The Randox Multidrug Calibrator Set is intended for use in the calibration of Methamphetamine, Barbiturates, Cocaine Metabolite, Methadone and Opiate assays.
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
DLJCalibrators, Drug Specific

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092266000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092266000RANDOX METHAMPHETAMINE ASSAYRandox Laboratories, Ltd.2011-05-09DKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273207880PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273207880050552732078805055273207880

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
+442894451070technical.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
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00812101031650ARK™ Ketamine II Calibrator (100 ng/mL Cutoff)ARK DIAGNOSTICS INCDLJ2025-12-27
00850624008650LZI Fentanyl Qualitative CalibratorLIN-ZHI INTERNATIONAL, INC.DLJ2025-10-13
00840937114636ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
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00840937114667ImmunalysisIMMUNALYSIS CORPDKB2024-04-19
00840937114568ImmunalysisIMMUNALYSIS CORPDLJ2024-04-08
00840937114605ImmunalysisIMMUNALYSIS CORPDLJ2024-04-08
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00613647025291FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.DKB2023-06-20
20613647025295FisherbrandFISHER SCIENTIFIC COMPANY L.L.C.DKB2023-06-20
04250317542397Urine Calibrator SetChromsystems Instruments + Chemicals GmbHDLJ2019-12-25
00840937111772ImmunalysisIMMUNALYSIS CORPDLJ2019-11-26
00840937111789ImmunalysisIMMUNALYSIS CORPDLJ2019-11-26
00840937111796ImmunalysisIMMUNALYSIS CORPDLJ2019-11-26
00840937111802ImmunalysisIMMUNALYSIS CORPDLJ2019-11-26
00840937108895ImmunalysisIMMUNALYSIS CORPDKB2019-09-16
00840937108901ImmunalysisIMMUNALYSIS CORPDKB2019-09-16
00840937111369ImmunalysisIMMUNALYSIS CORPDLJ2019-08-08
00812101030264ARK™ UR-144/JWH-018 Negative CalibratorARK DIAGNOSTICS INCDLJ2019-07-23
00812101030271ARK™ UR-144/JWH-018 Cutoff CalibratorARK DIAGNOSTICS INCDLJ2019-07-23
00812101030363ARK™ AB-PINACA Negative CalibratorARK DIAGNOSTICS INCDLJ2019-07-23
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