FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380175562
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
UA2ACR
Catalog number
UA2ACR
Device description
2 ACR Urine StripMicroalbuminCreatinineFor Urine
Published
2020-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
JFYENZYMATIC METHOD, CREATININE
JIRINDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
KQOAUTOMATED URINALYSIS SYSTEM

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380175563PackageGS110In Commercial Distribution
20885380175562PrimaryGS10
10885380175565Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538017556350885380175563
2088538017556220885380175562
1088538017556510885380175565

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 Temperature2 Degrees Celsius30 Degrees Celsius

Regulatory Flags#

DUNS number
961027315
Device count
100
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885380213281CARDINAL HEALTHCAH4403CAH44032026-05-27
10192253047486Telfa766776672025-09-08
50885380140233CONVERTORS8337N8337N2018-08-20
10192253047967Kendall92339233-2026-05-26
20192253019992Kendall33547T33547T--2026-05-26
10198956056497CARDINAL HEALTHPN69MSGADPN69MSGAD2026-05-25
10198956057005CARDINAL HEALTHSBACGDPMEDSBACGDPMED2026-05-25
10198956221161CARDINAL HEALTHSOP29PLCCYSOP29PLCCY2026-05-25
10198956253773CARDINAL HEALTHSOP56TKTCCSOP56TKTCC2026-05-25
10198956257610CARDINAL HEALTHSOPOCTKLHKSOPOCTKLHK2026-05-25
10198956258730CARDINAL HEALTHAMN4Q8277CAMN4Q8277C2026-05-25
10198956291812CARDINAL HEALTHSOP4FKPWFBSOP4FKPWFB2026-05-25
10198956300316CARDINAL HEALTH34-2071H34-2071H2026-05-25
10198956321632CARDINAL HEALTHSOPCGKHAUCSOPCGKHAUC2026-05-25
10198956325487CARDINAL HEALTHPO43LEUNCPO43LEUNC2026-05-25
10198956328457CARDINAL HEALTHPG4ETRHTCPG4ETRHTC2026-05-25
10198956340435CARDINAL HEALTH08-4609B08-4609B2026-05-25
10198956345645CARDINAL HEALTHSEYCGVPCPHSEYCGVPCPH2026-05-25
10198956348189CARDINAL HEALTHSBA48PPNSESBA48PPNSE2026-05-25
10198956350205CARDINAL HEALTHORC431774CORC431774C2026-05-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
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
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.KQO2025-09-18
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
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSKQO2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSKQO2024-06-05
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
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.KQO2023-06-08
00630414610962ADVIA CHEM Ecre3Siemens Healthcare Diagnostics Inc.JFY2022-12-22
17290017272471Minuteful - kidney testHEALTHY.IO LTDJFY2022-11-01
17290017272471Minuteful - kidney testHEALTHY.IO LTDJIR2022-11-01
17290017272471Minuteful - kidney testHEALTHY.IO LTDKQO2022-11-01
00630414610948Atellica CH ECRE3Siemens Healthcare Diagnostics Inc.JFY2022-09-30
10888277677791MedlineMEDLINE INDUSTRIES, INC.JIR2022-08-04