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
10198956182004CARDINAL HEALTHSOPCNEPBSFSOPCNEPBSF2026-07-06
10198956202320CARDINAL HEALTH34-9397L34-9397L2026-07-06
10198956261952CARDINAL HEALTH08-1780F08-1780F2026-07-06
10198956331235CARDINAL HEALTH32-7479R32-7479R2026-07-06
10198956358942CARDINAL HEALTHSEN4LTAGRCSEN4LTAGRC2026-07-06
10198956373068CARDINAL HEALTHSOP53HIOHCSOP53HIOHC2026-07-06
10198956373655CARDINAL HEALTHSANCGANMWCSANCGANMWC2026-07-06
10198956380615CARDINAL HEALTHENDDK4659DENDDK4659D2026-07-06
10198956381124CARDINAL HEALTH34-0950C34-0950C2026-07-06
10198956388789CARDINAL HEALTHSMA11DCWNFSMA11DCWNF2026-07-06
10198956389007CARDINAL HEALTHSEN35ENCFDSEN35ENCFD2026-07-06
10198956393424CARDINAL HEALTHSBADHLPNVCSBADHLPNVC2026-07-06
10198956397361CARDINAL HEALTHSAN29MY87ISAN29MY87I2026-07-06
10198956398689CARDINAL HEALTHSAN3MARCVCSAN3MARCVC2026-07-06
10198956407053CARDINAL HEALTHSOP69TJMSBSOP69TJMSB2026-07-06
10198956414693CARDINAL HEALTHSOP48TKLODSOP48TKLOD2026-07-06
10198956416079CARDINAL HEALTHPN11SF36DPN11SF36D2026-07-06
10198956416482CARDINAL HEALTHSAN11CC26CSAN11CC26C2026-07-06
10198956423077CARDINAL HEALTHPBCGDCBLIPBCGDCBLI2026-07-06
10198956427198CARDINAL HEALTHSBA13SMBTBSBA13SMBTB2026-07-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIR2026-06-03
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.KQO2026-02-06
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JFY2026-02-06
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.JFY2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06