5 Panel Drug Test Cup U-CUP-154

GUDID 20817038022287

5 Panel Drug Test Cup AMP/COC/OPI/THC/PCP

UCP BIOSCIENCES, INC.

Multiple drugs of abuse IVD, kit, rapid ICT, clinical
Primary Device ID20817038022287
NIH Device Record Key539ca687-c936-4fad-989e-17592285c917
Commercial Distribution Discontinuation2035-05-05
Commercial Distribution StatusIn Commercial Distribution
Brand Name5 Panel Drug Test Cup
Version Model NumberU-CUP-154
Catalog NumberU-CUP-154
Company DUNS163610020
Company NameUCP BIOSCIENCES, INC.
Device Count25
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Countertrue

Operating and Storage Conditions

Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius
Storage Environment TemperatureBetween 2 Degrees Celsius and 30 Degrees Celsius

Device Identifiers

Device Issuing AgencyDevice ID
GS100817038022283 [Unit of Use]
GS110817038022280 [Primary]
GS120817038022287 [Package]
Contains: 10817038022280
Package: Case [4 Units]
Discontinued: 2035-04-22
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DKZEnzyme Immunoassay, Amphetamine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-06-16
Device Publish Date2025-06-06

Devices Manufactured by UCP BIOSCIENCES, INC.

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20817038022218 - u-CardTM Drug Test Screen 12 Panel Test Card 2024-01-12 u-CardTM Drug Test Screen 12 Panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
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