FDA.reportPublic FDA data

Alltest Urinary Tract Infection Test

Primary DI
06942598216781
Brand
Alltest Urinary Tract Infection Test
Company
Hangzhou AllTest Biotech Co., Ltd.
Model
1
Catalog number
U031-A02H
Device description
3T FDA OTC
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
06942598216781PrimaryGS10
86942598216787Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06942598216781069425982167816942598216781
8694259821678786942598216787

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
3
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06942598249376One Step® Fentanyl(FYL1) Urine Test Panel1DFY-A114H2026-10-12
06942598249383One Step® Buprenorphine (BUP10) Home Rapid Test Dipstick1DBU-A101H2026-10-12
06942598249390One Step® Benzodiazepines (BZO300) Home Rapid Test Dipstick1DBZ-A101H2026-10-12
06942598249406One Step® Methamphetamine (MET500) Home Rapid Test Dipstick1DME-A101H2026-10-12
06942598249413One Step® Methadone (MTD300) Home Rapid Test Dipstick1DMT-A101H2026-10-12
06942598249420One Step® Morphine (MOP/OPI2000) Home Rapid Test Dipstick1DOP-A101H2026-10-12
16936983131633Multi-Drug Rapid Test Panel (Urine)1DOA-A1104C2026-04-16
16936983131640Multi-Drug Rapid Test Panel (Urine)1DOA-A1124C2026-04-16
16936983138632Multi-Drug 12 Drugs Rapid Test Cup1DOA-A1127C-062-b-A32026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test Cup1DUA-A1127C-A32026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test Cup1DUA-A1127C-A32026-04-16
16936983144664DiscoverDISP-CUP164N$2023-11-30
16936983144671DiscoverDISP-DUD6144N$2023-11-30
16936983144688Discover Multi-Drug 10 Drugs Rapid Test Cup (Urine)1DOA-A1107C-A32026-04-16
16936983149744Discover milti-drug 7 drugs rapid test cupDUA-A177C-A3 A1617DISP-DUD774N$2024-02-08
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)1DUA-A1137C-A32026-04-15
16936983165379Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine)1DUA-A157C-A32026-04-15
16936983169599Alltest Multi-Drug Rapid Urine Test Panel1DOA-A1144C-026-b2026-04-15
16936983169605Alltest Multi-Drug Rapid Urine Test Panel1DUA-A1144C-003-b2026-04-15
16936983169865Discover Multi-Drug 6 Drugs Rapid Test Cup (Urine)1DUA-A167C-A32026-04-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.LJX2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JMT2026-06-26
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JMT2026-06-03
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