FDA.reportPublic FDA data

HealthyMe UTI Urinary Tract Infection Test Strips

Primary DI
20682607651256
Brand
HealthyMe UTI Urinary Tract Infection Test Strips
Company
ACON LABORATORIES, INC.
Model
765100
Device description
Urinary Tract Infection home test with handle
Published
2024-03-27
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
JMTDIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10682607651259PackageGS16In Commercial Distribution
20682607651256PackageGS124In Commercial Distribution
00682607651252PrimaryGS10
00682607003150Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1068260765125910682607651259
2068260765125620682607651256
00682607651252006826076512526826076512520682607651252
00682607003150006826070031506826070031500682607003150

GMDN Terms#

Term, Definition table
TermDefinition
Urine leukocyte IVD, kit, rapid colorimetric, clinicalA 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 rapid colorimetric method. This is a rapid test commonly used in the laboratory or in point-of-care analyses. It is not intended to be used for self-testing.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
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#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00682607541072On Call Lancets (33G)G124-10AG124-10A2026-03-30
00682607541065On Call Lancing DeviceG124-11AG124-11A2026-03-18
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TC131-2041C131-20412026-03-09
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.JMT2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JMT2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-04-16
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.JMT2026-04-15
16936983186893DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-14
16936983192887Alltest Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983192894Alltest Multi-Drug 16 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983192900Alltest Multi-Drug 18 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197257Multi-Drug 8 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197264Multi-Drug 12 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16936983197271Multi-Drug 14 Drugs Rapid Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16942598200619Multi-Drug 9 Drugs Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.JMT2026-04-13
16942598203795DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.JMT2026-04-08
06942598204542Alltest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.JMT2026-04-08
06942598216781Alltest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.JMT2026-04-08
00677421450013NEW CHOICESCI Medic, Inc.JMT2026-03-26
00810164510624Atida Urinary Tract Infection TestACESO LABORATORIES INC.JMT2026-03-23
00860015215833Vivoo At-Home UTI Test StripsVIVOSENS INC.JMT2026-02-13
10860011489129Vivoo At-Home UTI Test StripsVIVOSENS INC.JMT2026-02-13
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JMT2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JMT2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JMT2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JMT2026-02-06
04987486053002S.G. Calibrator HARKRAY USA, INC.JMT2025-12-19
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JMT2025-09-18
00682607003433Mission Urinary Tract Infection (UTI) Test stripsAcon Laboratories, Inc.JMT2025-05-12
00846036009774GOODSENSEGEISS, DESTIN & DUNN, INCJMT2025-01-16
00860011489122Vivoo At-Home Urinary Tract Infection TestVIVOSENS INC.JMT2024-11-25
00860011489146Vivoo At-Home Urinary Tract Infection TestVIVOSENS INC.JMT2024-11-25
00850054026729QMedix™Diagnostic Automation, Inc.JMT2024-10-29