FDA.reportPublic FDA data

UCP Home Drug Screening Test Cups

Primary DI
10817038020552
Brand
UCP Home Drug Screening Test Cups
Company
UCP BIOSCIENCES, INC.
Model
U-CUP-3104
Catalog number
U-CUP-3104
Device description
10 Panel Drug Test Cup mAMP-COC-THC/MOP-MDMA/MTD/BAR-BZO/AMP/OXY
Published
2016-08-30
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

Product Codes#

Code, Name table
CodeName
DIOEnzyme Immunoassay, Cocaine And Cocaine Metabolites
DISEnzyme Immunoassay, Barbiturate
DJCThin Layer Chromatography, Methamphetamine
DJGEnzyme Immunoassay, Opiates
DJREnzyme Immunoassay, Methadone
DKZEnzyme Immunoassay, Amphetamine
JXMEnzyme Immunoassay, Benzodiazepine
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DIOEnzyme Immunoassay, Cocaine And Cocaine MetabolitesClinical Toxicology2
DISEnzyme Immunoassay, BarbiturateClinical Toxicology2
DJCThin Layer Chromatography, MethamphetamineClinical Toxicology2
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2
DJREnzyme Immunoassay, MethadoneClinical Toxicology2
DKZEnzyme Immunoassay, AmphetamineClinical Toxicology2
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K072062000
K091588000
K130463000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K072062000UCP MULTIPLE DRUG SCREEN TEST CUPSUcp Biosciences, Inc.2007-09-20LFG
K091588000UCP HOME DRUG SCREENING TESTSUcp Biosciences, Inc.2009-09-04DKZ
K130463000UCP HOME DRUG SCREENING TEST; CARDS, CUPSUcp Biosciences, Inc.2013-05-15DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817038020559PackageGS18In Commercial Distribution
10817038020552PrimaryGS10
00817038020555Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081703802055920817038020559
1081703802055210817038020552
00817038020555008170380205558170380205550817038020555

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 Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
163610020
Device count
25
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10817038021955u-Card TM Drug Test Screen 3 panel Test CardU-DOA-234LU-DOA-234L2018-11-01
10817038021962u-Cup TM Drug Test Screen 8 Panel Drug Test CupU-CUP-384U-CUP-3842018-11-01
10817038021979UCP Compact Drug Test CupsUCC-A1001M-A3AUCC-A1001M-A3A2018-11-26
10817038022044U-UCPTM Drug Test Screen 12 Panel Drug Test CupU-DUD-20124U-DUD-201242020-10-23
10817038022051u-CardTM Drug Test ScreenU-DOA-654U-DOA-6542020-11-09
10817038022068U-UCPTM Drug Test Screen 12 Panel Drug Test CupU-DUD-20124U-DUD-201242021-05-24
108170380220756 Panel Drug Test CupU-CUP-2064-3ADU-CUP-2064-3AD2021-10-13
10817038022099AYDMED Rapid Multi-Drug Test Dip CardDOA-3174-061DOA-3174-0612022-03-01
10817038022112u-Card Drug Test ScreenU-MET-114LU-MET-114L2022-06-16
10817038022129OEM 81-13 Drug Test U-DOA-134U-DOA-1342023-04-07
10817038022136OEM 81-13 Drug Test U-DOA-654U-DOA-6542023-04-07
10817038022143OEM 81-13 Drug Test U-DOA-254U-DOA-2542023-04-07
10817038022150OEM 81-13 Drug Test U-DOA-264U-DOA-2642023-04-07
10817038022167OEM 81-13 Drug Test U-DOA-244U-DOA-2442023-04-07
10817038022211u-CardTM Drug Test Screen 12 Panel Test Card U-DOA-20124U-DOA-201242024-01-04
10817038022228OEM 81-13 Drug Test 5 Panel Test CupU-CUP-654U-CUP-6542024-04-09
10817038022235OEM 81-13 Drug Test 6 Panel Test CupU-CUP-264U-CUP-2642024-04-09
10817038022242inSight 12 Panel Drug Test CupIS-12P-CWIS-12P-CW2024-05-16
1081703802225910 Panel Drug Test CupU-CUP-13104U-CUP-131042025-03-24
10817038022266u-CupTM Drug Test ScreenU-DUD-20124U-DUD-201242025-04-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810173656702AccurateHealgen Scientific Limited Liability CompanyLDJ2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDIO2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyJXM2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDIS2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJR2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDJG2026-06-02
00810173656702AccurateHealgen Scientific Limited Liability CompanyDKZ2026-06-02
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10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
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10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
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10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
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10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28