FDA.reportPublic FDA data

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

Primary DI
10810038631445
Brand
Easy@Home Urinary Tract Infection Test Strips (10 Pack)
Company
EASY HEALTHCARE CORPORATION
Model
EZU-101
Catalog number
EZU-101-10
Device description
Easy@Home Urinary Tract Infection Test Strips (10 Pack)
Published
2022-02-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Product Codes#

Code, Name table
CodeName
LJXTest, Urine Leukocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJXTest, Urine LeukocyteHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063295000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063295000ACON UTI URINARY TRACT INFECTION TEST STRIPSACON Laboratories, Inc.2007-10-12LJX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10810038631445PackageGS110In Commercial Distribution
00810038631448PrimaryGS10
30810038631449Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081003863144510810038631445
00810038631448008100386314488100386314480810038631448
3081003863144930810038631449

GMDN Terms#

Term, Definition table
TermDefinition
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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080278407
Device count
10
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810038637327Easy@Home Marijuana Test Cup(1 test kit)ECTH4-114A3ECTH4-114A3-12026-02-12
00810038638072Easy@Home FSH Urine Test (5 Tests)EFS1-MAEFS1-MA-52025-10-06
00810038638157Easy@Home Blood Pressure Monitor EBP-96BEBP-96B2025-07-31
00810038638850Easy@Home Digital Basal ThermometerEBT-100 BLUE2025-07-31
10810038638154Easy@Home Blood Pressure Monitor EBP-96BEBP-96B2025-07-31
10810038638857Easy@Home Digital Basal ThermometerEBT-100 BLUE2025-07-31
00810038638874Easy@Home Smart Basal ThermometerEBT-300 PINK2025-07-31
00810038638881Easy@Home Smart Basal ThermometerEBT-300 PURPLE2025-07-31
00810038638898Easy@Home Digital Basal ThermometerEBT-018 PINK2025-07-31
00810038638904Easy@Home Digital Basal ThermometerEBT-018 PURPLE2025-07-31
00810038638928Premom Smart Basal ThermometerEBT-3802025-07-31
00810038638935Easy@Home Digital ThermometerEMT-0262025-07-31
00810038638942Easy@Home Rectal Digital ThermometerEMT-0272025-07-31
00810038638959Easy@Home Digital ThermometerEMT-A122025-07-31
00810038638973Premom Smart Basal ThermometerEBT-3802025-07-31
00810038637150easy@Home PdG Urine Test StripEZW3-SEZW3-S-52025-07-24
00810038638041easy@Home PdG Urine Test StripEZW3-SEZW3-S-102025-07-24
10810038637157easy@Home PdG Urine Test StripEZW3-SEZW3-S-52025-07-24
10810038638048easy@Home PdG Urine Test StripEZW3-SEZW3-S-102025-07-24
00810038638867Easy@Home Digital Basal ThermometerEBT-100 PURPLE2025-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.LJX2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.LJX2026-04-16
16942598203795DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.LJX2026-04-08
06942598204542Alltest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.LJX2026-04-08
06942598216781Alltest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.LJX2026-04-08
00677421450013NEW CHOICESCI Medic, Inc.LJX2026-03-26
00810164510624Atida Urinary Tract Infection TestACESO LABORATORIES INC.LJX2026-03-23
06974246462936Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462943Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462950Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462967Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462974Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
06974246462981Exploro Urinary Tract Infection (UTI) TestSafecare Biotech (Hangzhou) Co., Ltd.LJX2026-03-09
00860015215833Vivoo At-Home UTI Test StripsVIVOSENS INC.LJX2026-02-13
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.LJX2025-09-18
06974246462363T Testahead URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2025-07-07
06974246462370T Testahead URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2025-07-07
00682607003433Mission Urinary Tract Infection (UTI) Test stripsAcon Laboratories, Inc.LJX2025-05-12
20682607610031Mission Urinary Tract Infection (UTI) Test stripsACON LABORATORIES, INC.LJX2025-05-12
00846036009774GOODSENSEGEISS, DESTIN & DUNN, INCLJX2025-01-16
00860011489122Vivoo At-Home Urinary Tract Infection TestVIVOSENS INC.LJX2024-11-25
00850054026729QMedix™Diagnostic Automation, Inc.LJX2024-10-29
06974246461663Welcheck URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2024-10-16
06974246461670Welcheck URINARY TRACT INFECTION TESTSafecare Biotech (Hangzhou) Co., Ltd.LJX2024-10-16
06971257037177urinalysis stripsWeihai Kangzheng Medical Equipment Technology Co., LtdLJX2024-06-22
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2024-06-14