FDA.reportPublic FDA data

MDMA CONTROL 2

Primary DI
05055273207941
Brand
MDMA CONTROL 2
Company
RANDOX LABORATORIES LIMITED
Model
DA3126
Catalog number
DA3126
Device description
The Randox Ecstasy Control Level 2 is intended for use in the Quality Control of the Ecstasy assay. The Ecstasy Control Level 2 contains the specific drug MDMA (3,4-methylenedioxymethamphetamine).
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
LASDrug Specific Control Materials

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LASDrug Specific Control MaterialsClinical Toxicology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K092275000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K092275000RANDOX ECSTASY (MDMA) ASSAYRandox Laboratories, Ltd.2011-03-01DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273207941PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273207941050552732079415055273207941

GMDN Terms#

Term, Definition table
TermDefinition
Amphetamine/methamphetamine group IVD, controlA material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of the amphetamine and/or methamphetamine group(s) in a clinical specimen.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Once opened the Ecstasy Quality Control materials are stable for 28 days at +2 to +8ºC.
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B8007HMG75UFKP07-HMG 75 NG/MLUTAK LABORATORIES, INC.LAS2026-04-02
B800ACETAHIGHV2UADX0ACETAMINOPHEN PLUS HIGH V2UTAK LABORATORIES, INC.LAS2026-01-16
B800ACETALOWV2UADX0ACETAMINOPHEN PLUS LOW V2UTAK LABORATORIES, INC.LAS2026-01-16
B80044600WBF10TCH0BLANK WHOLE BLOOD 10MLUTAK LABORATORIES, INC.LAS2025-10-29
B800AED1V3SHCMC0AED LEVEL 1 V3UTAK LABORATORIES, INC.LAS2025-08-25
B8006TGRQC1UK06TGR PLUS QC LEVEL 1UTAK LABORATORIES, INC.LAS2025-08-06
B8006TGRQC2UK06TGR PLUS QC LEVEL 2UTAK LABORATORIES, INC.LAS2025-08-06
B8006TGRQC3UK06TGR PLUS QC LEVEL 3UTAK LABORATORIES, INC.LAS2025-08-06
B80088121CDFASC0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2025-03-24
B80091801UAL0BUPRENORPHINE HYDROLYSIS QCUTAK LABORATORIES, INC.LAS2025-01-13
B80088121CDFL500NPM0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-12-20
B80044600WBF100MLRH0BLANK WHOLE BLOOD 100MLUTAK LABORATORIES, INC.LAS2024-12-11
B80090000UFLTI0NICOTINE PLUS LEVEL 1UTAK LABORATORIES, INC.LAS2024-09-30
B80090001UFLTI0NICOTINE PLUS LEVEL 2UTAK LABORATORIES, INC.LAS2024-09-30
B80088121CDFF10NJSP0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-09-18
B80088121CDFL50PML0CERTIFIED DRUG FREE URINE UTAK LABORATORIES, INC.LAS2024-09-05
B80011511050SMXHFAH0BLANK HAIR MATRIXUTAK LABORATORIES, INC.LAS2024-08-23
B800AEDSSCH0AED PLUSUTAK LABORATORIES, INC.LAS2024-07-17
B80044600WBFPOSAFT0POSITIVE WHOLE BLOODUTAK LABORATORIES, INC.LAS2024-05-20
B80088121CDFF10FS0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-05-06
B8007AMINOHIGHUPM07-AMINOCLONAZEPAM HIGHUTAK LABORATORIES, INC.LAS2024-05-03
B8007AMINOLOWUPM07-AMINOCLONAZEPAM LOWUTAK LABORATORIES, INC.LAS2024-05-03
B80088121CDFF100PDH0CERTIFIED DRUG FREE URINE 100MLUTAK LABORATORIES, INC.LAS2024-04-30
B80066815V3HRLC0HIGH RANGE TRACE ELEMENTS V3UTAK LABORATORIES, INC.LAS2024-04-03
B80066816V3NRLC0NORMAL RANGE TRACE ELEMENTS V3UTAK LABORATORIES, INC.LAS2024-04-03
B800ACETAUV4PM0ACETAMINOPHEN PLUS V4UTAK LABORATORIES, INC.LAS2024-03-12
B80092021IDC0SSRI 12 LEVEL 2UTAK LABORATORIES, INC.LAS2024-03-06
B800ACE250SFBSRHS0ACETONE 250 MG/DLUTAK LABORATORIES, INC.LAS2024-02-27
B80088121CDFLLTRWVDTL0CERTIFIED DRUG FREE URINEUTAK LABORATORIES, INC.LAS2024-02-20
B800ACIDNEUTQC0ACID-NEUT QCUTAK LABORATORIES, INC.LAS2024-02-16