National Test Systems UCC-10-1

GUDID 20817038021082

10-Panel Drug Test Cup COC/THC/OPI/AMP/MET/BZO/MTD/OXY/MDMA/BUP

UCP BIOSCIENCES, INC.

Multiple drugs of abuse IVD, kit, immunochromatographic test (ICT), rapid
Primary Device ID20817038021082
NIH Device Record Key62cdb0fa-56a5-4b01-9750-40a3106bba3f
Commercial Distribution StatusIn Commercial Distribution
Brand NameNational Test Systems
Version Model NumberUCC-10-1
Catalog NumberUCC-10-1
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
GS100817038021088 [Unit of Use]
GS110817038021085 [Primary]
GS120817038021082 [Package]
Contains: 10817038021085
Package: case [8 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 Date2021-05-24
Device Publish Date2016-09-30

On-Brand Devices [National Test Systems]

20817038021754National Test Systems 12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
20817038021747National Test Systems 12-Panel Drug Test Cup COC/THC/MOP/AMP/MET/PCP/BZO/BAR/MTD/OXY/MDMA/BUP
2081703802108210-Panel Drug Test Cup COC/THC/OPI/AMP/MET/BZO/MTD/OXY/MDMA/BUP
2081703802107510-Panel Drug Test Cup COC/THC/OPI/AMP/MET/BZO/MTD/OXY/MDMA/BUP

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