FDA.reportPublic FDA data

U-Cup TM Drug Test Screen

Primary DI
20817038021945
Brand
U-Cup TM Drug Test Screen
Company
UCP BIOSCIENCES, INC.
Model
U-CUP-564
Catalog number
U-CUP-564
Device description
U-Cup TM Drug Test Screen 6 Panel Drug Test Cup THC/BZO/OXY/OPI/COC/MET
Published
2017-10-24
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

Product Codes#

Code, Name table
CodeName
DJGEnzyme Immunoassay, Opiates

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DJGEnzyme Immunoassay, OpiatesClinical Toxicology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20817038021945PackageGS18In Commercial Distribution
10817038021948PrimaryGS10
00817038021941Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2081703802194520817038021945
1081703802194810817038021948
00817038021941008170380219418170380219410817038021941

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

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Primary DI, Brand, Company table
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