FDA.report

u-Cup Drug Test Screen

Primary DI
20817038021099
Brand
u-Cup Drug Test Screen
Company
UCP BIOSCIENCES, INC.
Model
U-CUP-20124
Catalog number
U-CUP-20124
Device description
12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
Published
2016-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
true
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
LDJEnzyme Immunoassay, Cannabinoids

Product Code Classifications

CodeDeviceSpecialtyClass
LDJEnzyme Immunoassay, CannabinoidsClinical Toxicology2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
20817038021099PackageGS18In Commercial Distribution
10817038021092PrimaryGS10
00817038021095Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
2081703802109920817038021099
1081703802109210817038021092
00817038021095008170380210958170380210950817038021095

GMDN Terms

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 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. It is not intended to be used for self-testing.

Storage And Handling

TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
163610020
Device count
25
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
208170380222709 Panel Drug Test CupU-CUP-794U-CUP-7942025-06-06
208170380222875 Panel Drug Test CupU-CUP-154U-CUP-1542025-06-06
20817038022263u-CupTM Drug Test ScreenU-DUD-20124U-DUD-201242025-04-09
0081703802225210 Panel Drug Test CupU-CUP-13104U-CUP-131042025-03-24
20817038022249inSight 12 Panel Drug Test CupIS-12P-CWIS-12P-CW2024-05-16
20817038022225OEM 81-13 Drug Test 5 Panel Test CupU-CUP-654U-CUP-6542024-04-09
20817038022232OEM 81-13 Drug Test 6 Panel Test CupU-CUP-264U-CUP-2642024-04-09
20817038022218u-CardTM Drug Test Screen 12 Panel Test Card U-DOA-20124U-DOA-201242024-01-04
20817038022201UCPU-MCUP-794U-MCUP-7942023-12-08
20817038021020UCP Home Pregnancy Dip CardUCD-Preg-CLIAUCD-Preg-CLIA2016-08-30
20817038021211UCP HOMEhCG striphCG strip2016-10-24
20817038021266UCP HomeU-HCG-101U-HCG-1012016-12-05
20817038021884UCP Home Pregnancy Test CassetteU-HCG-102U-HCG-1022017-01-20
20817038022171Number OneN1T-1126-PN1T-1126-P2023-06-16
20817038022188Number OneN1T-1127-PN1T-1127-P2023-06-16
20817038022195Number OneN1T-1105-PN1T-1105-P2023-06-16
20817038022126OEM 81-13 Drug Test U-DOA-134U-DOA-1342023-04-07
20817038022133OEM 81-13 Drug Test U-DOA-654U-DOA-6542023-04-07
20817038022140OEM 81-13 Drug Test U-DOA-254U-DOA-2542023-04-07
20817038022157OEM 81-13 Drug Test U-DOA-264U-DOA-2642023-04-07

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
80810164510736Atida Marijuana (THC) Drug of Abuse Strip Test RxACESO LABORATORIES INC.LDJ2026-03-23
M90107RD7205060QuickProfile™ Drugs of Abuse Test CupLUMIQUICK DIAGNOSTICS, INC.LDJ2026-03-11
M90107RD7205030QuickProfile™ Drugs of Abuse Test CupLUMIQUICK DIAGNOSTICS, INC.LDJ2026-03-10
M90107RD7205040QuickProfile™ Drugs of Abuse Test CupLUMIQUICK DIAGNOSTICS, INC.LDJ2026-03-10
B2986074060DrugCheckExpress Diagnostic Int'l, Inc.LDJ2026-03-09
00850013035786Identify Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2025-12-04
00850013035793Identify Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2025-12-04
00850013035816Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLDJ2025-12-04
00850013035823Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLDJ2025-12-04
00812203030872DrugSmartCHEMTRON BIOTECH INCLDJ2025-09-26
00850721007334Identify Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCLDJ2025-09-11
00850721007204Identify Diagnostics Drug Test CupsMEDICAL DISTRIBUTION GROUP INCLDJ2025-09-11
10810038638093Easy@Home Marijuana Test Strip(THC 20)EASY HEALTHCARE CORPORATIONLDJ2025-07-10
10816862027324Prime ScreenWONDFO USA CO., LTD.LDJ2025-07-03
26952804810461Marijuana Test StripASSURE TECH. (HANGZHOU) CO., LTD.LDJ2025-03-18
10815845024299SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.LDJ2024-12-17
00049696712675VeriQuickFOURSTAR GROUP INC.LDJ2024-12-05
06972412611966LyherHangzhou Laihe Biotech Co.,Ltd.LDJ2024-11-12
06972412619696LyherHangzhou Laihe Biotech Co.,Ltd.LDJ2024-11-12
10810038636990Areta Multi-Drug Test Cup (25 tests kit)EASY HEALTHCARE CORPORATIONLDJ2024-09-30
40810038636434Easy@Home Multi-Drug Screen Test (5 tests kit)EASY HEALTHCARE CORPORATIONLDJ2024-07-17
00812203030773Premier BiotechCHEMTRON BIOTECH INCLDJ2024-05-28
00722066008362Rapid ResponseBTNX IncLDJ2024-02-26
00812203030681GenericCHEMTRON BIOTECH INCLDJ2024-02-05
00850040879162Number 1DEUS VULT, LLCLDJ2024-02-01
10810124273092SureStepTM Urine Test Drug Screen Strip, Marijuana (THC 50)ALERE SAN DIEGO, INC.LDJ2023-12-15
10810124273337SureStepTM Urine Drug Test CassetteALERE SAN DIEGO, INC.LDJ2023-12-15
10810124273788CERTUM THC One Step Marijuana Test StripALERE SAN DIEGO, INC.LDJ2023-12-15
00850013035502Identify Health MEDICAL DISTRIBUTION GROUP INCLDJ2023-12-07
10816862023760Prime ScreenWONDFO USA CO., LTD.LDJ2023-08-03