FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380175548
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
UA10ACR
Catalog number
UA10ACR
Device description
10ACR Urine Strip LeukocytesNitriteBloodpHCreatinineSpecific GravityKetonesMicroalbuminProteinGlucoseFor 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
JILMETHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
JINNITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
JIOBLOOD, OCCULT, COLORIMETRIC, IN URINE
JIRINDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
JMTDIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
JREREFRACTOMETER FOR CLINICAL USE
KQOAUTOMATED URINALYSIS SYSTEM
LJXTEST, URINE LEUKOCYTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JFYEnzymatic Method, CreatinineClinical Chemistry2
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2
JINNitroprusside, Ketones (Urinary, Non-Quant.)Clinical Chemistry1
JIOBlood, Occult, Colorimetric, In UrineHematology2
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
JRERefractometer For Clinical UseClinical Chemistry1
KQOAutomated Urinalysis SystemClinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380175549PackageGS110In Commercial Distribution
20885380175548PrimaryGS10
10885380175541Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538017554950885380175549
2088538017554820885380175548
1088538017554110885380175541

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
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.LJX2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JMT2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIO2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIN2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JRE2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.KQO2025-09-18
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIR2025-09-18
08806141303497One+Step 10ADFI CO.,LTDJIR2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJRE2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJIN2023-10-16
08806141303497One+Step 10ADFI CO.,LTDJMT2023-10-16
08806141303480One+Step UTIDFI CO.,LTDJMT2023-10-14
00860010249000Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
00860010249017Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
00860010249024Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJMT2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIN2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJRE2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIO2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIL2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDLJX2020-09-22
08806141302209Just Fitter 10 Parameter Test Strips DFI CO.,LTDJIR2020-09-22
08806141302070CYBOW 10DFI CO.,LTDLJX2020-06-29
08806141302070CYBOW 10DFI CO.,LTDJIN2020-06-29
08806141302070CYBOW 10DFI CO.,LTDJIR2020-06-29
08806141302070CYBOW 10DFI CO.,LTDJRE2020-06-29
08806141302070CYBOW 10DFI CO.,LTDJIL2020-06-29
08806141302070CYBOW 10DFI CO.,LTDJMT2020-06-29
08806141301998Yodoc 10DFI CO.,LTDJIO2020-02-20
08806141301998Yodoc 10DFI CO.,LTDJIR2020-02-20