Easy@Home Urinary Tract Infection Test Strips (10 Pack) EZU-101-10

GUDID 10810038631445

Easy@Home Urinary Tract Infection Test Strips (10 Pack)

EASY HEALTHCARE CORPORATION

Multiple urinary tract infection-associated bacteria nucleic acid IVD, kit, nucleic acid technique (NAT)
Primary Device ID10810038631445
NIH Device Record Keyff433665-1815-427a-b91d-30f619cea853
Commercial Distribution StatusIn Commercial Distribution
Brand NameEasy@Home Urinary Tract Infection Test Strips (10 Pack)
Version Model NumberEZU-101
Catalog NumberEZU-101-10
Company DUNS080278407
Company NameEASY HEALTHCARE CORPORATION
Device Count10
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 Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Device Identifiers

Device Issuing AgencyDevice ID
GS100810038631448 [Primary]
GS110810038631445 [Package]
Contains: 00810038631448
Package: 10 [10 Units]
In Commercial Distribution
GS130810038631449 [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

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