U-UCPTM Drug Test Screen 12 Panel Drug Test Cup U-DUD-20124

GUDID 20817038022065

U-UCPTM Drug Test Screen 12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC with Adulteration strip (S.G./CRE/pH)

UCP BIOSCIENCES, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID20817038022065
NIH Device Record Key4d7c5e25-b23e-4e79-8622-fb6b1f8109cc
Commercial Distribution Discontinuation2030-05-23
Commercial Distribution StatusIn Commercial Distribution
Brand NameU-UCPTM Drug Test Screen 12 Panel Drug Test Cup
Version Model NumberU-DUD-20124
Catalog NumberU-DUD-20124
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
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
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
GS100817038022061 [Unit of Use]
GS110817038022068 [Primary]
GS120817038022065 [Package]
Contains: 10817038022068
Package: case [8 Units]
Discontinued: 2030-05-23
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJREnzyme Immunoassay, Methadone

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-01
Device Publish Date2021-05-24

On-Brand Devices [U-UCPTM Drug Test Screen 12 Panel Drug Test Cup]

20817038022041U-UCPTM Drug Test Screen 12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC
20817038022065U-UCPTM Drug Test Screen 12 Panel Drug Test Cup AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/MOP/OXY/PCP/THC

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