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
20885380173544Curity9022G9022G2019-11-14
20885380173568Curity9024G9024G2019-11-14
10198956038127CARDINAL HEALTHSAN22IAMRASAN22IAMRA2026-10-19
10198956180000CARDINAL HEALTHPUV2KPMHBPUV2KPMHB2026-10-19
10198956268111CARDINAL HEALTHSNECGACSGESNECGACSGE2026-10-19
10198956377967CARDINAL HEALTHSBA56MIMCFSBA56MIMCF2026-10-19
10198956384774CARDINAL HEALTHSVA42LVGLCSVA42LVGLC2026-10-19
10198956390799CARDINAL HEALTHSEYCGEPAZBSEYCGEPAZB2026-10-19
10198956400795CARDINAL HEALTHSOP3MKPCVDSOP3MKPCVD2026-10-19
10198956414815CARDINAL HEALTHSMA41PGEPBSMA41PGEPB2026-10-19
10198956441811CARDINAL HEALTHSCV29VPPCUSCV29VPPCU2026-10-19
10198956462328CARDINAL HEALTHSCV13PPBTESCV13PPBTE2026-10-19
10198956464988CARDINAL HEALTHSOP51XRKKPSOP51XRKKP2026-10-19
10198956499270CARDINAL HEALTHPG33BGMKBPG33BGMKB2026-10-19
10198956499980CARDINAL HEALTH33-2528E33-2528E2026-10-19
10198956506732CARDINAL HEALTHSOP41TPDSFSOP41TPDSF2026-10-19
10198956513587CARDINAL HEALTHSAN33CACHNSAN33CACHN2026-10-19
10198956514874CARDINAL HEALTHSOPOCTKSBBSOPOCTKSBB2026-10-19
10198956516922CARDINAL HEALTHPC23TAAMEPC23TAAME2026-10-19
10198956518964CARDINAL HEALTHSAN40CCAEGSAN40CCAEG2026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888277664395MEDLINEMEDLINE INDUSTRIES, INC.KQO2026-10-01
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JFY2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JFY2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIR2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.KQO2026-06-26
06972164410008LOOKEE® AscleTrack™ Urine Test AnalyzerKunming Lianen Biotechnology Co., LTDKQO2026-06-26
06972164410022LOOKEE® AscleTrack™ Urine Microalbumin (MAU) Test StripKunming Lianen Biotechnology Co., LTDJIR2026-06-26
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
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.JIR2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-03
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