FDA.reportPublic FDA data

UCP Drug Test Mini Cups

Primary DI
10817038021771
Brand
UCP Drug Test Mini Cups
Company
UCP BIOSCIENCES, INC.
Model
U-MDUD4A-10124
Catalog number
U-MDUD4A-10124
Device description
UCP Drug Test Mini Cups 12-Panel Drug Test Mini Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/AMP/TCA/BUP with Adulteration strip (OX/S.G./CRE/pH)
Published
2017-01-20
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
LFGRadioimmunoassay, Tricyclic Antidepressant Drugs

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
LFGRadioimmunoassay, Tricyclic Antidepressant DrugsClinical Toxicology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K151213000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151213000UCP Drug Test Mini CupsUcp Biosciences, Inc.2015-08-21DKZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817038021778PackageGS18In Commercial Distribution
10817038021771PrimaryGS10
00817038021774Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081703802177820817038021778
1081703802177110817038021771
00817038021774008170380217748170380217740817038021774

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
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035400Identify®Diagnostics Drug Test DipMEDICAL 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
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035417Identify®Diagnostics Drug Test DipsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJC2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJR2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035424Identify®Diagnostics Drug Test DipMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDKZ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDJG2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIO2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCJXM2026-05-28
10850013035530Identify®Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCDIS2026-05-28