FDA.reportPublic FDA data

CARDINAL HEALTH

Primary DI
20885380175555
Brand
CARDINAL HEALTH
Company
Cardinal Health 200, LLC
Model
UA10SGL
Catalog number
UA10SGL
Device description
10 SGL Urine StripLeukocytesNitriteUrobilinogenProteinpHBloodSpecific GravityKetonesBilirubinGlucoseFor 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
CDMDIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
CENDye-indicator, pH (urinary, non-quantitative)
JILMETHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)
JINNITROPRUSSIDE, KETONES (URINARY, NON-QUANT.)
JIOBLOOD, OCCULT, COLORIMETRIC, IN URINE
JIRINDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)
JJBAZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (URINARY, NON-QUANT.)
JMTDIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)
LJXTEST, URINE LEUKOCYTE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical Chemistry1
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1
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
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.)Clinical Chemistry1
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1
LJXTest, Urine LeukocyteHematology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50885380175556PackageGS110In Commercial Distribution
20885380175555PrimaryGS10
10885380175558Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
5088538017555650885380175556
2088538017555520885380175555
1088538017555810885380175558

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
10197106911266CARDINAL HEALTHSBA60POLHCSBA60POLHC2026-06-08
10197106983577CARDINAL HEALTHSEN69ERMVDSEN69ERMVD2026-06-08
10198956182264CARDINAL HEALTHSCV43OOTGKSCV43OOTGK2026-06-08
10198956218611CARDINAL HEALTHSOP55AOKFJSOP55AOKFJ2026-06-08
10198956227552CARDINAL HEALTHSEY33EPCAFSEY33EPCAF2026-06-08
10198956279391CARDINAL HEALTH01-0111A01-0111A2026-06-08
10198956312920CARDINAL HEALTHSMA57CESARSMA57CESAR2026-06-08
10198956332096CARDINAL HEALTHSOP32THGMLSOP32THGML2026-06-08
10198956336865CARDINAL HEALTHPN73CRKPBPN73CRKPB2026-06-08
10198956343139CARDINAL HEALTHSOP45HAOCCSOP45HAOCC2026-06-08
10198956359024CARDINAL HEALTHSBA24UPJRGSBA24UPJRG2026-06-08
10198956362932CARDINAL HEALTHSEN48TASABSEN48TASAB2026-06-08
10198956364349CARDINAL HEALTHSBACGRPGRASBACGRPGRA2026-06-08
10198956364783CARDINAL HEALTHSNE38LMCIBSNE38LMCIB2026-06-08
10198956373372CARDINAL HEALTHSOP31EXHNGSOP31EXHNG2026-06-08
10198956373976CARDINAL HEALTHSOP38SHUSHSOP38SHUSH2026-06-08
10198956374119CARDINAL HEALTHSBA56LPSTCSBA56LPSTC2026-06-08
10198956386150CARDINAL HEALTHSEN69SPREBSEN69SPREB2026-06-08
10198956387171CARDINAL HEALTHSBA41PLRSESBA41PLRSE2026-06-08
10198956390430CARDINAL HEALTHSEN37TSPSDSEN37TSPSD2026-06-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIO2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CDM2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.CEN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIN2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JJB2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.LJX2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JMT2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JJB2026-06-03