FDA.reportPublic FDA data

iScreen™

Primary DI
10817405021328
Brand
iScreen™
Company
Instant Technologies, Inc.
Model
IS12BUP-DX2
Catalog number
IS12BUP-DX2
Device description
iScreen™ Urine Test Drug Screen Card 12 Panel (AMP/BAR/BUP/BZO/COC/MDMA/MET/MOP/MTD/OXY/TCA/THC)
Published
2020-08-21
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LAFGas Chromatography, Methamphetamine
LDJEnzyme Immunoassay, Cannabinoids
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LAFGas Chromatography, MethamphetamineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133968000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133968000WONDFO MULTI-DRUG URINE TEST CUP, PANELGuangzhou Wondfo Biotech Co., Ltd.2014-02-25DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817405021328PrimaryGS10
00817405021321Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081740502132810817405021328
00817405021321008174050213218174050213210817405021321

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, rapid ICT, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method [lateral flow test]. This is a rapid test used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature4 Degrees Celsius30 Degrees Celsius

Contacts#

Phone, Email table
PhoneEmail
800-340-4029qa.portsmouth@abbott.com

Regulatory Flags#

DUNS number
019410187
Device count
25
Kit
true
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00817405024025iCassetteABTDFYW11201AABTDFYW11201A2023-11-30
00817405021154UScreen®USSCup-10MUSSCup-10M2021-01-13
00817405021192UScreen®USSCupA-12CLIAUSSCUPA-12CLIA2021-01-13
00817405021222UScreen®USSCup-10MMO300USSCup-10MMO3002021-01-13
10817405021304iScreen™IS1 MET-DX2 IS1 MET-DX2 2020-08-21
10817405021311iScreen™IS12-DX2 IS12-DX2 2020-08-21
10817405021373UScreen®USSCupA-11CLIALCUSSCupA-11CLIALC2021-05-25
00817405022229iScreen™ABTDUAW110704DABTDUAW110704D2022-06-16
00817405023240iScreen™ABTDUAW112701AABTDUAW112701A2022-11-09
00817405023257iScreen™ABTDUAW16701AABTDUAW16701A2022-11-09
00817405023264iScreen™ABTDUAW17701AABTDUAW17701A2022-11-09
00817405023271iScreen™ABTDUAW110701AABTDUAW110701A2022-11-09
00817405023288iScreen™ABTDUAW110702BABTDUAW110702B2022-11-09
00817405023295iScreen™ABTDUAW15701AABTDUAW15701A2022-11-09
00817405023301iScreen™ABTDUAW113701AABTDUAW113701A2023-02-10
00817405023318iScreen™ABTDOAW14701AABTDOAW14701A2022-11-09
00817405023325iScreen™ABTDUAW17702BABTDUAW17702B2022-11-09
00817405023332iScreen™ABTDOAW17701AABTDOAW17701A2022-11-09
00817405023349iScreen™ABTDUAW110703CABTDUAW110703C2022-11-09
00817405023356iScreen™ABTDUAW111701AABTDUAW111701A2022-11-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10612479255293McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJR2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LAF2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479255323McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DKZ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.JXM2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIO2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LDJ2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DIS2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.DJG2020-06-18
10612479258430McKessonMCKESSON MEDICAL-SURGICAL INC.LFG2020-06-18
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.LDJ2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.JXM2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DIO2017-11-15
M09107RD7065220QuickProfile™ Drugs of Abuse Panel 6 TestLUMIQUICK DIAGNOSTICS, INC.DJG2017-11-15
10694644100010Rapid TOXAMERICAN BIO MEDICA CORPORATIONLFG2016-09-23