Easy@Home Urinary Tract Infection Test Strips (20 Pack)

Basic Information

• Brand Name: Easy@Home Urinary Tract Infection Test Strips (20 Pack)
• Primary DI: 00810038633473
• Version / Model: EZU-101
• Catalog Number: EZU-101-20
• Company Name: EASY HEALTHCARE CORPORATION
• Labeler DUNS: 080278407
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 20
• Record Status: Published
• Publish Date: 2022-02-17
• Public Version: 1
• Public Version Date: 2022-02-25
• Public Version Status: New
• Public Device Record Key: 6b35e319-814a-4413-8d9d-469756c6dc1d

Device Description

Easy@Home Urinary Tract Infection Test Strips (20 Pack)

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• 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
LJX	Test, Urine Leukocyte	Hematology	864.7675	1
JMT	Diazo (Colorimetric), Nitrite (Urinary, Non-Quant)	Clinical Chemistry	862.1510	1

GMDN Terms

Code	Name	Definition	Implantable	Status
64635	Multiple urinary tract infection-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids from multiple bacteria associated with urinary tract infection (UTI) in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Bacteria detected may include (but are not limited to) Escherichia, Klebsiella, Enterococcus, and Streptococcus species.	No	Active
65139	Multiple urinary tract pathogen nucleic acid IVD, kit, nucleic acid technique (NAT)	A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of nucleic acids and/or genes conferring antimicrobial resistance from multiple types of pathogens for the differentiation and/or identification of pathogens typically associated with urinary tract infection (UTI) in a clinical specimen and/or culture isolate, using a nucleic acid technique (NAT). Pathogens detected may include bacteria, viruses, fungi and/or parasites such as (but are not limited to) Staphylococcus saprophyticus, Klebsiella aerogenes, Klebsiella pneumoniae, Candida albicans and Corynebacterium urealyticum.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00810038633473	GS1
Unit of Use	30810038633474	GS1

Premarket Submissions

Submission Number	Supplement Number
K063295	000