u-Card Drug Test Screen U-OPI-114L

GUDID 20817038021822

u-Card Drug Test Screen Opiates Single Panel Dip Test Card

UCP BIOSCIENCES, INC.

Opiate/opiate metabolite IVD, kit, rapid ICT, clinical
Primary Device ID20817038021822
NIH Device Record Key0c11e17d-43d0-4747-9de1-2602ed504e29
Commercial Distribution StatusIn Commercial Distribution
Brand Nameu-Card Drug Test Screen
Version Model NumberU-OPI-114L
Catalog NumberU-OPI-114L
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
GS100817038021828 [Unit of Use]
GS110817038021825 [Primary]
GS120817038021822 [Package]
Contains: 10817038021825
Package: case [40 Units]
In Commercial Distribution

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 Number3
Public Version Date2022-06-10
Device Publish Date2017-01-20

On-Brand Devices [u-Card Drug Test Screen]

20817038021907u-Card Drug Test Screen 11 Panel Test Card THC/COC/OPI/AMP/BZO/BAR/MET/OXY/MTD/BUP/TCA)
20817038021853u-Card Drug Test Screen 5 panel Test Card(AMP/COC/OPI/PCP/THC)
2081703802136512 panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC with Adulteration strip(S.G
2081703802135812 panel Test Card AMP/BAR/BUP/BZO/COC/MET/MDMA/MTD/OPI/OXY/PCP/THC
20817038021198THC Single Panel Dip Test Card
2081703802116710 panel Test Card AMP/BAR/BZO/COC/MET/MTD/OPI/OXY/PCP/THC
208170380211506 panel Test Card AMP/BZO/COC/MET/OPI/THC
208170380211435 panel Test Card AMP/COC/MET/OPI/THC
20817038021877u-Card Drug Test Screen AMP Single Panel Dip Test Card
20817038021846u-Card Drug Test Screen MOP Single Panel Dip Test Card
20817038021839u-Card Drug Test Screen OXY Single Panel Dip Test Card
20817038021822u-Card Drug Test Screen Opiates Single Panel Dip Test Card
20817038021204BUP Single Panel Dip Test Card
20817038022119MET Single Panel Dip Test Card
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