FDA.reportPublic FDA data

HealthyMe UTI Urinary Tract Infection Test Strips

Primary DI
20682607651003
Brand
HealthyMe UTI Urinary Tract Infection Test Strips
Company
ACON LABORATORIES, INC.
Model
765100
Device description
Urinary Tract Infection home test
Published
2020-04-30
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

Contact Domains#

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
20682607651003PackageGS124In Commercial Distribution
00682607651009PrimaryGS10
00682607002085Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068260765100320682607651003
00682607651009006826076510096826076510090682607651009
00682607002085006826070020856826070020850682607002085

GMDN Terms#

Term, Definition table
TermDefinition
Urine leukocyte IVD, kit, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for leukocytes within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep out of direct sunlight
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)838-9502support@aconlabs.com

Regulatory Flags#

DUNS number
781100966
Device count
3
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#

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Primary DIBrandModelCatalogPublished
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00682607690077Mission Cholesterol Optical Check DeviceC121-2021C121-20212026-03-09
00682607690084Mission Cholesterol Control SolutionC121-2011C121-20112026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TC131-2041C131-20412026-03-09
10682607690050Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TC131-2041C131-20412026-03-09
00682607690060Mission Cholesterol MeterC111-2021C111-20212026-03-09
10682607690074Mission Cholesterol Optical Check DeviceC121-2021C121-20212026-03-09
10682607690081Mission Cholesterol Control SolutionC121-2011C121-20112026-03-09
10682607690098Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TC131-2041C131-20412026-03-09
00682607541058On Call Lancets 30GG124-10AG124-10A2026-02-19
10682607541055On Call Lancets 30GG124-10AG124-10A2026-02-19
20682607200485Mission U120 Smart Urine AnalyzerU117-1012026-02-06
20682607200492Mission U120 Smart Urine AnalyzerU117-1112026-02-06
20682607200904Mission U120 Touch Urine AnalyzerU119-106-1012026-02-06
20682607200911Mission U120 Touch Urine AnalyzerU119-116-1012026-02-06
00682607541829On Call Stealth Lancing DeviceG124-18AG124-18A2026-02-03
20682607541823On Call Stealth Lancing DeviceG124-18AG124-18A2026-02-03
00810107290002Flowflex Plus COVID-19 + Flu A/B Home TestL03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945L03A-R0645, L03A-R0745, L03A-R0845, L03A-R09452026-01-30

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
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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