FDA.reportPublic FDA data

Exploro Urinary Tract Infection (UTI) Test

Primary DI
06974246462974
Brand
Exploro Urinary Tract Infection (UTI) Test
Company
Safecare Biotech (Hangzhou) Co., Ltd.
Model
4 tests
Catalog number
UTI-1
Published
2026-03-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

Product Codes#

Code, Name table
CodeName
LJXTest, Urine Leukocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LJXTest, Urine LeukocyteHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06974246462974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06974246462974069742464629746974246462974

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative detection of urine for multiple analytes 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 to screen for non-microbial markers associated with a urinary tract infection (UTI) [e.g., leukocytes, blood, nitrites, proteins]. It is not intended to be used for self-testing.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
544349634
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06974246462905Safecare Vaginal PH Rapid Test Cassette3 TestsPH-60122026-03-18
06974246462936Exploro Urinary Tract Infection (UTI) Test15 testsUTI-12026-03-09
06974246462943Exploro Urinary Tract Infection (UTI) Test10 testsUTI-12026-03-09
06974246462950Exploro Urinary Tract Infection (UTI) Test7 testsUTI-12026-03-09
06974246462967Exploro Urinary Tract Infection (UTI) Test5 testsUTI-12026-03-09
06974246462981Exploro Urinary Tract Infection (UTI) Test3 testsUTI-12026-03-09
06974246462851Analysis Oasis Marijuana (THC) Urine Strip Test25 TestsTHC-10112026-02-04
06974246462868Analysis Oasis Marijuana (THC) Urine Strip Test15 TestsTHC-10112026-02-04
06974246462875Analysis Oasis Marijuana (THC) Urine Strip Test10 TestsTHC-10112026-02-04
06974246462882Analysis Oasis Marijuana (THC) Urine Strip Test5 TestsTHC-10112026-02-04
06974246462899Analysis Oasis Marijuana (THC) Urine Strip Test3 TestsTHC-10112026-02-04
06974246462813Deteta THC Urine Test15 TestsD.1012025-11-05
06974246462820Deteta THC Urine Test10 TestsD.1012025-11-05
06974246462837Deteta THC Urine Test5 TestsD.1012025-11-05
06974246462424Exploro Highly Sensitive Urine Drug Test (14-Panel)10 testsMULTID14-12025-07-30
06974246462431Exploro Highly Sensitive Urine Drug Test (14-Panel)5 testsMULTID14-12025-07-30
06974246462448Exploro Highly Sensitive Urine Drug Test (14-Panel)4 testsMULTID14-12025-07-30
06974246462455Exploro Highly Sensitive Urine Drug Test (14-Panel)3 testsMULTID14-12025-07-30
06974246462462Exploro Highly Sensitive Urine Drug Test (14-Panel)2 testsMULTID14-12025-07-30
06974246462479Exploro Highly Sensitive Urine Drug Test (14-Panel)1 testMULTID14-12025-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.LJX2026-06-03
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
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