UCP Home Drug Screening Test Cards U-OPI-114

GUDID 20817038020474

OPI 2000 Single Panel Dip Test Card

UCP BIOSCIENCES, INC.

Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
Primary Device ID20817038020474
NIH Device Record Key6f199e8a-4852-4bae-88aa-673c8f1a1979
Commercial Distribution StatusIn Commercial Distribution
Brand NameUCP Home Drug Screening Test Cards
Version Model NumberU-OPI-114
Catalog NumberU-OPI-114
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100817038020470 [Unit of Use]
GS110817038020477 [Primary]
GS120817038020474 [Package]
Contains: 10817038020477
Package: case [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DJGEnzyme Immunoassay, Opiates

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2022-06-10
Device Publish Date2016-08-30

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

20817038021471UCP Home Drug Screening Test Cards 12 Panel Drug Test Card BZO/BAR/COC/THC/mAMP/MOP/MTD/TCA/OXY/
20817038021457UCP Home Drug Screening Test Cards THC Single Panel Dip Test Card
20817038020504THC Single Panel Dip Test Card
2081703802049812 Panel Drug Test Card BZO/BAR/COC/THC/mAMP/MOP/MTD/TCA/OXY/MDMA/PCP/AMP
208170380204816 Panel Drug Test Card COC/AMP/mAMP/THC/OPI/BZO
20817038021914UCP Home Drug Screening Test Cards MDMA Single Panel Dip Test Card
20817038021709UCP Home Drug Screening Test Cards OXY Single Panel Dip Test Card
20817038021570UCP Home Drug Screening Test Cards AMP Single Panel Dip Test Card
20817038021563UCP Home Drug Screening Test Cards PCP Single Panel Dip Test Card
20817038021556UCP Home Drug Screening Test Cards OPI 2000 Single Panel Dip Test Card
20817038021549UCP Home Drug Screening Test Cards MTD Single Panel Dip Test Card
20817038021532UCP Home Drug Screening Test Cards OPI 300 Single Panel Dip Test Card
20817038021525UCP Home Drug Screening Test Cards MDMA Single Panel Dip Test Card
20817038021518UCP Home Drug Screening Test Cards mAMP Single Panel Dip Test Card
20817038021501UCP Home Drug Screening Test Cards COC Single Panel Dip Test Card
20817038021495UCP Home Drug Screening Test Cards BZO Single Panel Dip Test Card
20817038021488UCP Home Drug Screening Test Cards BAR Single Panel Dip Test Card
20817038021464UCP Home Drug Screening Test Cards BUP Single Panel Dip Test Card
20817038020870OXY Single Panel Dip Test Card
20817038020863BUP Single Panel Dip Test Card
20817038020825BUP Single Panel Dip Test Card
20817038020474OPI 2000 Single Panel Dip Test Card
20817038020467OPI300 Single Panel Dip Test Card
20817038020450MTD Single Panel Dip Test Card
20817038020443COC Single Panel Dip Test Card
20817038020436BZO Single Panel Dip Test Card
20817038020429AMP Single Panel Dip Test Card
20817038020412mAMP Single Panel Dip Test Card
20817038020405MDMA Single Panel Dip Test Card
20817038020399PCP Single Panel Dip Test Card
20817038020382BAR Single Panel Dip Test Card
20817038020023TCA Single Panel Dip Test Card
20817038020009OXY Single Panel Dip Test Card
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