FDA.reportPublic FDA data

Alltest Urinary Tract Infection Test

Primary DI
06942598204542
Brand
Alltest Urinary Tract Infection Test
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
1
Catalog number
U031-A02H
Device description
1T FDA OTC, EN
Published
2026-04-08
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
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
LJXTest, Urine Leukocyte

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252607000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252607000AllTest Urinary Tract Infection TestHangzhou AllTest Biotech Co., Ltd.2025-10-30JMT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06942598204542PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942598204542069425982045426942598204542

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.

Regulatory Flags#

DUNS number
543254717
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06936983113793Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)1FHC-A2022026-04-22
06936983113809Alltest Pregnancy Rapid Combo Test Cassette(Urine/Serum)1FHC-A2022026-04-22
06936983114721Alltest BZO300 Home Rapid Test Panel (Urine)1DBZ-A114H (300ng)2026-04-22
06936983114738Alltest BAR300 Home Rapid Test Panel (Urine)1DBA-A114H (300ng)2026-04-22
06936983114745Alltest AMP500 Home Rapid Test Panel (Urine)1DAM-A114H (500ng)2026-04-22
06936983114752Alltest MOP2000 Home Rapid Test Panel(Urine)1DOP-A114H (2000ng)2026-04-22
06936983114769Alltest MOP300 Home Rapid Test Panel (Urine)1DMO-A114H (300ng)2026-04-22
06936983113939Alltest MDMA500 Rapid Test Panel (Urine)1DMD-A114 (500ng)2026-04-21
06936983113946Alltest MET500 Rapid Test Panel (Urine)1DME-A114 (500ng)2026-04-21
06936983113953Alltest MOP300 Rapid Test Panel (Urine)1DMO-A114 (300ng)2026-04-21
06936983113960Alltest MTD300 Rapid Test Panel (Urine)1DMT-A114 (300ng)2026-04-21
06936983113977Alltest MOP2000 Rapid Test Panel (Urine)1DOP-A114 (2000ng)2026-04-21
06936983113984Alltest OXY100 Rapid Test Panel (Urine)1DOX-A114 (100ng)2026-04-21
06936983113991Alltest PCP25 Rapid Test Panel (Urine)1DPC-A114 (25ng)2026-04-21
06936983114004Alltest TCA1000 Rapid Test Panel (Urine)1DTC-A114 (1000ng)2026-04-21
06936983114011Alltest THC50 Rapid Test Panel (Urine)1DTH-A114 (50ng)2026-04-21
06936983114028Alltest AMP500 Rapid Test Dipstick (Urine)1DAM-A101 (500ng)2026-04-21
06936983114035Alltest BAR300 Rapid Test Dipstick (Urine)1DBA-A101 (300ng)2026-04-21
06936983114042Alltest BUP10 Rapid Test Dipstick (Urine)1DBU-A101 (10ng)2026-04-21
06936983114059Alltest BZO300 Rapid Test Dipstick (Urine)1DBZ-A101 (300ng)2026-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
16942598203795DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.LJX2026-04-08
00677421450013NEW CHOICESCI Medic, Inc.LJX2026-03-26
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JMT2026-02-06
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.LJX2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JMT2026-02-06
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
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JMT2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.LJX2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JMT2025-09-18
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSLJX2024-06-06
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJMT2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJMT2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSLJX2024-06-04
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJMT2024-06-04
00630414631677Clinistix UTI Test StripsSiemens Healthcare Diagnostics Inc.LJX2024-02-21
00630414631677Clinistix UTI Test StripsSiemens Healthcare Diagnostics Inc.JMT2024-02-21
08806141303497One+Step 10ADFI CO.,LTDJMT2023-10-16
08806141303480One+Step UTIDFI CO.,LTDJMT2023-10-14