FDA.reportPublic FDA data

One+Step Salive & Urine pH

Primary DI
08806141303060
Brand
One+Step Salive & Urine pH
Company
DFI CO.,LTD
Model
31I4
Device description
100strips/ 1 bottle
Published
2022-10-03
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)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806141303060PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806141303060088061413030608806141303060

GMDN Terms#

Term, Definition table
TermDefinition
Urine pH IVD, kit, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine to determine pH within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
688779180
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true
No natural rubber latex
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
08806141303480One+Step UTI33742023-10-14
08806141301592QTEST K01242022-10-14
08806141302025One+Step Protein81942022-10-03
08806141302643One+Step pH81742022-10-03
08806141302650One+Step Ketone81A42022-10-03
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
16936983131695Multi-Drug Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983141120Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983141137Discover Multi-Drug 12 Drugs Rapid Test Cup Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983144770Discover Multi-Drug 9 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983148846Discover Multi-Drug 12 Drugs Rapid Test Cup (Urine) Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-16
16936983153819Discover Multi-Drug 13 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983165379Discover Multi-Drug 5 Drugs Rapid Test Cup(Urine) Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983169605Alltest Multi-Drug Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983169865Discover Multi-Drug 6 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983169872Discover Multi-Drug 8 Drugs Rapid Test Cup (Urine)Hangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983170038Alltest Multi-Drug 14 Drugs Urine Test PanelHangzhou AllTest Biotech Co., Ltd.CEN2026-04-15
16936983172414Alltest Multi-Drug 13 Drugs Rapid Urine Test PanelHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983180600Alltest Multi-Drug 13 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983180617Alltest Multi-Drug 14 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983181270Alltest Multi-Drug 9 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983186077Alltest Multi-Drug 14 Drugs Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983186893DrugTect Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187074Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187081Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
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16936983187104Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187135Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187142Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187159Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187166Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187173Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187180Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187203Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16936983187210Discover Multi-Drug Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14
16942598222673Alltest Multi-Drug 18 Drugs Urine Test CupHangzhou AllTest Biotech Co., Ltd.CEN2026-04-14