FDA.reportPublic FDA data

UScreen®

Primary DI
00817405021192
Brand
UScreen®
Company
Instant Technologies, Inc.
Model
USSCupA-12CLIA
Catalog number
USSCUPA-12CLIA
Device description
U-Screen Squared Integrated CLIA Waived Cup with Adulterants (CR,SG,PH) 12 Panel Drug Screen for (THC/COC/MOP/AMP/MET/BAR/BZO/PCP/MDMA/MTD/OXY/TCA)
Published
2021-01-13
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
LCMEnzyme Immunoassay, Phencyclidine
NFTTest, Amphetamine, Over The Counter
NFVTest, Benzodiazepine, Over The Counter
NFWTest, Cannabinoid, Over The Counter
NFYTest, Cocaine And Cocaine Metabolites, Over The Counter
NGGTest, Methamphetamine, Over The Counter
NGLTest, Opiates, Over The Counter
PTGTest, Methadone, Over The Counter
PTHTest, Barbiturate, Over The Counter
QAWTest, Tricyclic Antidepressants, Over The Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LCMEnzyme Immunoassay, PhencyclidineUnknownU
NFTTest, Amphetamine, Over The CounterClinical Toxicology2
NFVTest, Benzodiazepine, Over The CounterClinical Toxicology2
NFWTest, Cannabinoid, Over The CounterClinical Toxicology2
NFYTest, Cocaine And Cocaine Metabolites, Over The CounterClinical Toxicology2
NGGTest, Methamphetamine, Over The CounterClinical Toxicology2
NGLTest, Opiates, Over The CounterClinical Toxicology2
PTGTest, Methadone, Over The CounterClinical Toxicology2
PTHTest, Barbiturate, Over The CounterClinical Toxicology2
QAWTest, Tricyclic Antidepressants, Over The CounterClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182701000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182701000Wondfo T-Cup Multi-Drug Urine Test CupGuangzhou Wondfo Biotech Co., Ltd.2018-12-03NFT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00858998006128PreviousGS10
00817405021192PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00858998006128008589980061288589980061280858998006128
00817405021192008174050211928174050211920817405021192

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
1-800-340-4029Qa.Portsmouth@abbott.com

Regulatory Flags#

DUNS number
019410187
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
00817405024025iCassetteABTDFYW11201AABTDFYW11201A2023-11-30
00817405021154UScreen®USSCup-10MUSSCup-10M2021-01-13
00817405021222UScreen®USSCup-10MMO300USSCup-10MMO3002021-01-13
10817405021304iScreen™IS1 MET-DX2 IS1 MET-DX2 2020-08-21
10817405021311iScreen™IS12-DX2 IS12-DX2 2020-08-21
10817405021328iScreen™IS12BUP-DX2 IS12BUP-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
10722066018009Rapid ResponseBTNX IncPTH2026-07-14
10722066018009Rapid ResponseBTNX IncPTG2026-07-14
10722066018009Rapid ResponseBTNX IncNGL2026-07-14
10722066018009Rapid ResponseBTNX IncNGG2026-07-14
10722066018009Rapid ResponseBTNX IncNFY2026-07-14
10722066018009Rapid ResponseBTNX IncNFW2026-07-14
10722066018009Rapid ResponseBTNX IncNFV2026-07-14
10722066018009Rapid ResponseBTNX IncQAW2026-07-14
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNFW2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGG2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNGL2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNFY2026-07-09
10858886006855Noble Drug Test Cup with AD (Urine)NOBLE MEDICAL INCNFT2026-07-09
00841824104167ECOIIW.H.P.M. INC.LCM2026-07-07
00810174471229Prime Screen®WONDFO USA CO., LTD.NFY2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NFT2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.LCM2026-06-26
00810174471229Prime Screen®WONDFO USA CO., LTD.NFW2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFW2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGL2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NGG2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFY2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFV2026-06-26
00810174471410Prime Screen®WONDFO USA CO., LTD.NFT2026-06-26
00810173656726HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656733HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656740HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656757HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03
00810173656764HealgenHealgen Scientific Limited Liability CompanyLCM2026-06-03