AccessGUDID - DEVICE: UCP Home Drug Screening Test Cards (10817038020019)

GUDID

Device Identifier (DI) Information

Brand Name: UCP Home Drug Screening Test Cards
Version or Model: U-PPX-114
Commercial Distribution Status: In Commercial Distribution
Catalog Number: U-PPX-114
Company Name: UCP BIOSCIENCES, INC.

Primary DI Number: 10817038020019
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 25
Labeler D-U-N-S® Number*: 163610020 *Terms of Use

Device Description: PPX Single Panel Dip Test Card

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	Yes
For Single-Use:	Yes
Prescription Use (Rx):	Yes
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JXN	Enzyme Immunoassay, Propoxyphene

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130463	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 30 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: e928d5bb-f2f8-4e11-8d56-29544a17bc56
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 30, 2016