FDA.reportPublic FDA data

URiSCAN 1 Glucose strip

Primary DI
08806125680156
Brand
URiSCAN 1 Glucose strip
Company
YD Diagnostics CORP.
Model
U191
Device description
Urinalysis dip and read strips for visual.Test for Glucose in urine.
Published
2019-11-13
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
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K952307000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K952307000BIOSCANBiosys Laboratories, Inc.1995-09-05JIL

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806125680156PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806125680156088061256801568806125680156

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte 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 for multiple analytes 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
687769737
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08806125630229OcculTech Fecal Occult Blood Rapid TestIM706-100M2019-08-13
08806125680019URiSCAN 10 SGL stripU3912016-08-05
08806125680033URiSCAN 2 GP stripU2012016-09-01
08806125680064URiSCAN 6 L stripU2512016-09-01
08806125680217URiSCAN 10 SGL stripU7742016-12-21
08806125680224URiSCAN 2 ACR stripU6432016-08-05
08806125680231URiSCAN 10 ACR stripU6212016-08-05
08806125680279UCARE 11 StickP4112017-07-28
08806125680286UCARE 11 StickP4122017-07-28
08806125680071URiSCAN 1 Ketones stripU1512019-11-13
08806125619033URiSCAN OptimaOptima2016-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIL2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIL2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
00015482104658AUTION MAX™ AX-4060 AnalyzerARKRAY USA, INC.JIL2025-11-07
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIL2025-09-18
00015482117313AUTION MAX™ AX-4060 AnalyzerARKRAY USA, INC.JIL2024-12-02
00850054026729QMedix™Diagnostic Automation, Inc.JIL2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIL2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-04
10673486002416Teco Diagnostics Urine Reagent Strips (URS-1G)TECO DIAGNOSTICSJIL2024-03-22
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JIL2023-06-08
10888277720336MedlineMEDLINE INDUSTRIES, INC.JIL2022-12-10
10884389181966MedlineMEDLINE INDUSTRIES, INC.JIL2022-10-28