UCP Home Drug Screening Test Cups U-CUP-3124-RCN

GUDID 20817038021600

UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/TCA/OXY/MDMA/PCP/AMP

UCP BIOSCIENCES, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID20817038021600
NIH Device Record Keya703ed5d-4291-4722-aa80-3a6c33435531
Commercial Distribution StatusIn Commercial Distribution
Brand NameUCP Home Drug Screening Test Cups
Version Model NumberU-CUP-3124-RCN
Catalog NumberU-CUP-3124-RCN
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817038021606 [Unit of Use]
GS110817038021603 [Primary]
GS120817038021600 [Package]
Contains: 10817038021603
Package: case [8 Units]
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 StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2021-05-24
Device Publish Date2017-01-20

On-Brand Devices [UCP Home Drug Screening Test Cups]

20817038021921UCP Home Drug Screening Test Cups 10 Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MTD/OPI30
20817038021808UCP Home Drug Screening Test Cups 10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MT
20817038021792UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MT
20817038021785UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MT
20817038021631UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MT
20817038021624UCP Home Drug Screening Test Cups 10 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/M
20817038021617UCP Home Drug Screening Test Cups 6 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY/AMP
20817038021600UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MT
20817038021594UCP Home Drug Screening Test Cups 12 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MT
20817038021587UCP Home Drug Screening Test Cups 5 Panel Drug Screening Test Cup BZO/COC/THC/OPI300/OXY
208170380206658 Panel Drug Screening Test Cup BZO/BAR/COC/MET/OPI300/MTD/OXY/AMP
2081703802065812 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/TCA/OXY/MDMA/PCP/AMP
2081703802064113 Panel Drug Screening Test Cup AMP/BAR/BZO/COC/MET/MDMA/MTD/OPI300/OXY/PCP/BUP/TCA/THC
2081703802063412 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/AMP/TCA/BUP with Adu
208170380206276 Panel Drug Screening Test Cup BZO/COC/MET/OPI300/OXY/AMP
208170380206105 Panel Drug Screening Test Cup BZO/THC/OPI300/OXY/BUP
2081703802060312 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/TCA/OXY/MDMA/AMP/BUP
208170380205976 Panel Drug Screening Test Cup BZO/COC/OPI300/OXY/AMP/BUP
2081703802058012 Panel Drug Screening Test Cup BZO/BAR/COC/THC/MET/OPI300/MTD/OXY/MDMA/AMP/PPX/BUP
208170380205736 Panel Drug Screening Test Cup BZO/COC/THC/MET/OPI300/AMP
208170380205665 Panel Drug Screening Test Cup BZO/COC/MET/OPI300/OXY
2081703802055910 Panel Drug Test Cup mAMP-COC-THC/MOP-MDMA/MTD/BAR-BZO/AMP/OXY
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