UCP Home Drug Screening Test Strips U-PCP-101

GUDID 20817038021990

UCP Home Drug Screening Test Strips Phencyclidine Test Strip

UCP BIOSCIENCES, INC.

Phencyclidine (PCP) IVD, kit, rapid ICT, clinical
Primary Device ID20817038021990
NIH Device Record Key8cdfe94b-9942-4066-b2db-6edb01112f59
Commercial Distribution StatusIn Commercial Distribution
Brand NameUCP Home Drug Screening Test Strips
Version Model NumberU-PCP-101
Catalog NumberU-PCP-101
Company DUNS163610020
Company NameUCP BIOSCIENCES, INC.
Device Count50
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
GS100817038021996 [Unit of Use]
GS110817038021993 [Primary]
GS120817038021990 [Package]
Contains: 10817038021993
Package: case [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LCMEnzyme Immunoassay, Phencyclidine

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2022-06-10
Device Publish Date2019-01-31

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

20817038021426UCP Home Drug Screening Test Strips Marijuana Test Strip
20817038022003UCP Home Drug Screening Test Strips Methamphetamine Test Strip
20817038021990UCP Home Drug Screening Test Strips Phencyclidine Test Strip
20817038021983UCP Home Drug Screening Test Strips Amphetamine Test Strip
20817038021440UCP Home Drug Screening Test Strips Methamphetamines Test Strip
20817038021433UCP Home Drug Screening Test Strips Opiates Test Strip

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