FDA.reportPublic FDA data

U-Screen

Primary DI
00858998006029
Brand
U-Screen
Company
Instant Tech Subsidiary Acquisition
Model
USSCup-10MMO300
Catalog number
USSCup-10MMO300UScreen with 10 Panel Drug Screen f
Device description
UScreen with 10 Panel Drug Screen for (THC/COC/OPI300/AMP/MET/BAR/BZO/MDMA/MTD/OXY)
Published
2016-10-26
Public version status
Update
Distribution status
Not 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

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

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
00858998006029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858998006029008589980060298589980060290858998006029

GMDN Terms#

Term, Definition table
TermDefinition
Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative detection of one or multiple drugs of abuse in a clinical specimen within a short period, relative to standard laboratory testing procedures, using an immunochromatographic test (ICT) method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888.669.4337james.harvey@usdiagnostics.com

Regulatory Flags#

DUNS number
080317182
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
00858998006012U-ScreenUSSCup-10MUSSCup-10M2016-10-26
00858998006036U-ScreenUSSCup-5MUSSCup-5M2016-10-26
00858998006050U-ScreenUSSCup-7BO CLIAUSSCup-7BO CLIA2016-10-26
00858998006067U-ScreenUSSCupA-10MUSSCupA-10M2016-10-26
00858998006081U-ScreenUSSCupA-10MOB-300CLIAUSSCupA-10MOB-300CLIA2016-10-26
00858998006098U-ScreenUSSCupA-12USSCupA-122016-10-26
00858998006111U-ScreenUSSCupA-12BUP300CLIAUSSCupA-12BUP300CLIA2016-10-26
00858998006128U-ScreenUSSCupA-12CLIAUSSCupA-12CLIA2016-10-26
00858998006135U-ScreenUSSCupA-12NTCLIAUSSCupA-12NTCLIA2016-10-26
00858998006142U-ScreenUSSCupA-5MUSSCupA-5M2016-10-26
00858998006180U-ScreenUSSCupA-7MOBCLIAUSSCupA-7MOBCLIA2016-10-26
00858998006197U-ScreenUSSDip-6MBUSSDip-6MB2016-10-26
00858998006203ProScreenPSD-10MOBPSD-10MOB2016-09-19
00858998006234ProScreenPSD-10MOXPSD-10MOX2016-09-19
00858998006302ProScreenPSDA-5MPSDA-5M2016-09-19
00858998006326ProScreenPSDA-6CM5PSDA-6CM52016-09-22
00858998006333ProScreenPSDA-6MPPSDA-6MP2016-09-19
00858998006357ProScreenPSDA-8CM5PSDA-8CM52016-09-22
00858998006388ProScreenPSDA-8MBO300PSDA-8MBO3002016-09-19
00858998006418U-ScreenUSSCup-4NTUSSCup-4NT2017-12-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00817405024247iScreen™Instant Technologies, Inc.LDJ2026-08-01
00817405024247iScreen™Instant Technologies, Inc.LAF2026-08-01
00817405024247iScreen™Instant Technologies, Inc.JXM2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DJG2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIS2026-08-01
00817405024247iScreen™Instant Technologies, Inc.DIO2026-08-01
00810173656719HealgenHealgen Scientific Limited Liability CompanyLDJ2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIO2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyLAF2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJG2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyJXM2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDJR2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDIS2026-07-31
00810173656719HealgenHealgen Scientific Limited Liability CompanyDKZ2026-07-31
B07609700LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
B07609710LZI Fentanyl III Enzyme ImmunoassayLIN-ZHI INTERNATIONAL, INC.DJG2026-07-17
00841824104167ECOIIW.H.P.M. INC.DKZ2026-07-07
00841824104167ECOIIW.H.P.M. INC.JXM2026-07-07
00841824104167ECOIIW.H.P.M. INC.DIS2026-07-07
00841824104167ECOIIW.H.P.M. INC.DIO2026-07-07
00841824104167ECOIIW.H.P.M. INC.LAF2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJR2026-07-07
00841824104167ECOIIW.H.P.M. INC.DJG2026-07-07
00841824104167ECOIIW.H.P.M. INC.LDJ2026-07-07
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
10850013035431Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDKZ2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDJG2026-06-25
10850013035448Identify Health Drug Screen Test CupMEDICAL DISTRIBUTION GROUP INCDIO2026-06-25