FDA.reportPublic FDA data

Evidence MultiSTAT DOA Urine MultiPlex

Primary DI
05055273216752
Brand
Evidence MultiSTAT DOA Urine MultiPlex
Company
RANDOX LABORATORIES LIMITED
Model
EV4393
Catalog number
EV4393
Device description
The Evidence MultiSTAT DOA Urine MultiPlex is intended for use with the Evidence MultiSTAT. The Evidence MultiSTAT is an analyzer intended for the qualitative determination of parent drug molecule and metabolites of drugs in human urine at the associated cut offs.
Published
2024-09-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DISEnzyme Immunoassay, Barbiturate
DJGEnzyme Immunoassay, Opiates
LCMEnzyme Immunoassay, Phencyclidine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
LCMEnzyme Immunoassay, PhencyclidineUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K221550000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K221550000Evidence MultiSTAT DOA Urine MultiPlexRandox Laboratories Limited2023-10-05DJG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05055273216752PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05055273216752050552732167525055273216752

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, multiplexA collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of one or multiple drugs of abuse in a clinical specimen, using a multiplex method.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LCM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2020-05-29
10694644100454Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2020-05-29
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2019-02-12
10694644100447Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2019-02-12
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2018-03-30
10694644100430Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2018-03-30
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDIS2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONDJG2017-06-08
10694644100423Rapid TOXAMERICAN BIO MEDICA CORPORATIONLCM2017-06-08
10694644200017RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644200017RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2016-09-23
10694644200024RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2016-09-23
10694644200024RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644200031RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644200031RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2016-09-23
10694644200048RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONLCM2016-09-23
10694644200048RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2016-09-23
10694644200055RTCII 1st gen.AMERICAN BIO MEDICA CORPORATIONDJG2016-09-23