FDA.reportPublic FDA data

One+Step UTI

Primary DI
08806141303480
Brand
One+Step UTI
Company
DFI CO.,LTD
Model
3374
Device description
The one device included 100 Strips
Published
2023-10-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

Product Codes#

Code, Name table
CodeName
CENDye-Indicator, Ph (Urinary, Non-Quantitative)
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)
LJXTest, Urine Leukocyte

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806141303480PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806141303480088061413034808806141303480

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Humidity2 Degrees Celsius30 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688779180
Device count
1
Premarket exempt
true
Kit
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806141304043ONE+Step Uric Acid31H72025-09-04
08806141304036ONE+Step Uric Acid31H12025-09-03
08806141304029ONE+Step Uric Acid31H7P2025-08-22
08806141303701Newfoundland Cholesterol Test64502024-05-29
08806141303497One+Step 10A30D42023-10-16
08806141301592QTEST K01242022-10-14
08806141302025One+Step Protein81942022-10-03
08806141302643One+Step pH81742022-10-03
08806141302650One+Step Ketone81A42022-10-03
08806141303060One+Step Salive & Urine pH31I42022-10-03
08806141303077One+Step Uric Acid31H0P2022-10-03
08806141302896QUCARE®Self Total Cholesterol 64072022-07-26
08806141302674QUCARE®Self Total Cholesterol 6400P2022-07-25
08806141302766Just Fitter pH Test Strips31KC2022-04-25
08806141300755CYBOW 110A942016-10-06
08806141301479QTEST™ 1109942018-12-21
08806141302209Just Fitter 10 Parameter Test Strips 30C42020-09-22
08806141302070CYBOW 1000042020-06-29
08806141302087CYBOW P 01432020-06-29
08806141302094CYBOW P01442020-06-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
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.LJX2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
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
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
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
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.CEN2026-06-03
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
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.CEN2026-06-03