FDA.reportPublic FDA data

u-Cup Drug Test Screen

Primary DI
20817038021297
Brand
u-Cup Drug Test Screen
Company
UCP BIOSCIENCES, INC.
Model
U-CUP-174
Catalog number
U-CUP-174
Device description
7 Panel Drug Test Cup AMP/BZO/COC/MET/OPI/OXY/THC
Published
2016-12-05
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

Product Codes#

Code, Name table
CodeName
JXMEnzyme Immunoassay, Benzodiazepine

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JXMEnzyme Immunoassay, BenzodiazepineClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817038021297PackageGS18In Commercial Distribution
10817038021290PrimaryGS10
00817038021293Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081703802129720817038021297
1081703802129010817038021290
00817038021293008170380212938170380212930817038021293

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 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#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
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 DI, Brand, Model table
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 DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10810173655993HealgenHealgen Scientific Limited Liability CompanyJXM2026-03-11
10810173655597HealgenHealgen Scientific Limited Liability CompanyJXM2026-02-04
10810173655658HealgenHealgen Scientific Limited Liability CompanyJXM2026-02-04
00810173655101HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-31
10810173655603HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-30
10810173655641HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-30
00810173654821HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-08
00810173654838HealgenHealgen Scientific Limited Liability CompanyJXM2026-01-08
00850054026989QMedix™Diagnostic Automation, Inc.JXM2025-12-23
00850054026996QMedix™Diagnostic Automation, Inc.JXM2025-12-23
10810173654002HealgenHealgen Scientific Limited Liability CompanyJXM2025-12-19
10810173654149HealgenHealgen Scientific Limited Liability CompanyJXM2025-12-19
10810173654644HealgenHealgen Scientific Limited Liability CompanyJXM2025-12-19
00850013035830Identify®Diagnostics Drug Test Cups MEDICAL DISTRIBUTION GROUP INCJXM2025-12-04
0081703802225210 Panel Drug Test CupUCP BIOSCIENCES, INC.JXM2025-03-24
10815845024305SureStep™ Urine Test Drug Screen StripALERE SAN DIEGO, INC.JXM2024-12-17
00841824105409N/AW.H.P.M. INC.JXM2024-06-14
10810124273023SureStepTM Urine Test Drug Screen Strip, Benzodiazepines (BZO 300)ALERE SAN DIEGO, INC.JXM2023-12-15
10810124273283SureStep™ Urine Test Drug Screen Cassette, Benzodiazepines (BZO 300)ALERE SAN DIEGO, INC.JXM2023-12-15
10810124273726CERTUM BZO One Step Benzodiazepines Test StripALERE SAN DIEGO, INC.JXM2023-12-15
00817763022367First SignHEMOSURE INC.JXM2023-05-18
04015630999347ONLINE DAT Benzodiazepines IIRoche Diagnostics GmbHJXM2023-05-11
07613336121054ONLINE DAT Benzodiazepines IIRoche Diagnostics GmbHJXM2023-05-11
00850041101750Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
00850041101781Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
00850041101798Onsite DrugScreenMedical Disposables CorpJXM2023-04-24
10817405022936iCup™Instant Technologies, Inc.JXM2023-02-09
30817405022282iScreen™Instant Technologies, Inc.JXM2023-02-07
30817405022565iCassette™Instant Technologies, Inc.JXM2023-02-07
B77830573OD0Origin Instant Dip Drug TestORIGIN DIAGNOSTICS LLCJXM2022-12-07