Easy@Home Urinary Tract Infection Test Strips (20 Pack) EZU-101-20

GUDID 00810038633473

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

EASY HEALTHCARE CORPORATION

Multiple urinary tract infection-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID00810038633473
NIH Device Record Key6b35e319-814a-4413-8d9d-469756c6dc1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Urinary Tract Infection Test Strips (20 Pack)
Version Model NumberEZU-101
Catalog NumberEZU-101-20
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count20
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810038633473 [Primary]
GS130810038633474 [Unit of Use]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LJXTest, Urine Leukocyte

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-02-25
Device Publish Date2022-02-17

Devices Manufactured by EASY HEALTHCARE CORPORATION

10810038638154 - Easy@Home Blood Pressure Monitor 2025-08-08
10810038638857 - Easy@Home Digital Basal Thermometer2025-08-08
00810038638874 - Easy@Home Smart Basal Thermometer2025-08-08
00810038638881 - Easy@Home Smart Basal Thermometer2025-08-08
00810038638898 - Easy@Home Digital Basal Thermometer2025-08-08
00810038638904 - Easy@Home Digital Basal Thermometer2025-08-08
00810038638928 - Premom Smart Basal Thermometer2025-08-08
00810038638935 - Easy@Home Digital Thermometer2025-08-08

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.