UCP Home Drug Screening Test Cards

Basic Information

• Brand Name: UCP Home Drug Screening Test Cards
• Primary DI: 10817038020019
• Version / Model: U-PPX-114
• Catalog Number: U-PPX-114
• Company Name: UCP BIOSCIENCES, INC.
• Labeler DUNS: 163610020
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 25
• Record Status: Published
• Publish Date: 2016-08-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: e928d5bb-f2f8-4e11-8d56-29544a17bc56

Device Description

PPX Single Panel Dip Test Card

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): Yes
• Over the Counter (OTC): Yes
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: Yes
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
JXN	Enzyme Immunoassay, Propoxyphene	Clinical Toxicology	862.3700	2

GMDN Terms

Code	Name	Definition	Implantable	Status
55764	Propoxyphene IVD, kit, enzyme immunoassay (EIA)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of propoxyphene in a clinical specimen, using an enzyme immunoassay (EIA) method.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	20817038020016	GS1	case	40	In Commercial Distribution
Primary	10817038020019	GS1
Unit of Use	00817038020012	GS1

Premarket Submissions

Submission Number	Supplement Number
K130463	000

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 30 Degrees Celsius