FDA.reportPublic FDA data

URiSCAN 2 ACR strip

Primary DI
08806125680224
Brand
URiSCAN 2 ACR strip
Company
YD Diagnostics CORP.
Model
U643
Device description
Urinalysis dip and read strips for URiSCAN urine analyzer.Test for Microalbumin and Creatinine in urine.
Published
2016-08-05
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
JFYEnzymatic Method, Creatinine
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFYEnzymatic Method, CreatinineClinical Chemistry2
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K141874000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K141874000URISCAN OPTIMAYd Diagnostics Corp.2015-05-28KQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08806125680224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08806125680224088061256802248806125680224

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 (strip) method. This test is 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].

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
08806125680231URiSCAN 10 ACR stripU6212016-08-05
08806125680279UCARE 11 StickP4112017-07-28
08806125680286UCARE 11 StickP4122017-07-28
08806125680071URiSCAN 1 Ketones stripU1512019-11-13
08806125680156URiSCAN 1 Glucose stripU1912019-11-13
08806125619033URiSCAN OptimaOptima2016-08-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIR2026-06-03
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIR2025-09-18
10884389181942MEDLINEMEDLINE INDUSTRIES, INC.JIR2025-04-29
16936983168646DrugTect Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JFY2025-02-13
16936983168646DrugTect Multi-Drug 14 Drugs Rapid Urine Test CupHangzhou AllTest Biotech Co., Ltd.JIR2025-02-13
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIR2024-06-04
00630414631707Clinistix Kidney Health Test SystemSiemens Healthcare Diagnostics Inc.JFY2024-05-03
00630414631707Clinistix Kidney Health Test SystemSiemens Healthcare Diagnostics Inc.JIR2024-05-03
08806141303497One+Step 10ADFI CO.,LTDJIR2023-10-16
00630414610962ADVIA CHEM Ecre3Siemens Healthcare Diagnostics Inc.JFY2022-12-22
17290017272471Minuteful - kidney testHEALTHY.IO LTDJFY2022-11-01
17290017272471Minuteful - kidney testHEALTHY.IO LTDJIR2022-11-01