FDA.reportPublic FDA data

Medline

Primary DI
10888277677791
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MPHUAMAC
Catalog number
MPHUAMAC
Device description
STRIPS,URINE,REAGENT,ALB/CRE,25 STRIPS
Published
2022-08-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JIRINDICATOR METHOD, PROTEIN OR ALBUMIN (URINARY, NON-QUANT.)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JIRIndicator Method, Protein Or Albumin (Urinary, Non-Quant.)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888277677791PrimaryGS10
80888277677790Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827767779110888277677791
8088827767779080888277677790

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
Special Storage Condition, Specify00Keep out of direct sunlight
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)633-5463service@medline.com

Regulatory Flags#

DUNS number
025460908
Device count
25
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
30197344020779MEDLINEDYND364951DYND3649512026-08-19
00080196549422MEDLINE486800PL486800PL2025-05-06
00197344024936MEDLINEMG5002MG50022024-03-13
00888277172015MEDLINESG310SG3102024-05-02
00888277327552MEDLINE486802PL486802PL2025-03-25
00888277327569MEDLINE486803PL486803PL2025-03-25
00888277327576MEDLINE486804PL486804PL2025-03-25
00888277415075MEDLINE486801PL486801PL2025-05-06
40080196294344MEDLINEMDR107003LMDR107003L2020-10-12
40080196320999MEDLINEMDR107002EMDR107002E2016-10-14
40080196321002MEDLINEMDR107003EMDR107003E2016-10-14
10889942000388NAMICDYNJCAPDYNJCAP2026-08-18
10889942000395NAMICDYNJCAPRDYNJCAPR2026-08-18
20197344158895MEDLINEMDT12080XLMDT12080XL2026-08-18
20197344158918MEDLINEMDT12081LMDT12081L2026-08-18
20197344158932MEDLINEMDT12083LMDT12083L2026-08-18
20197344158956MEDLINEMDT12083XLMDT12083XL2026-08-18
20197344158970MEDLINEMDT12084XLMDT12084XL2026-08-18
20197344158987MEDLINEMDT12085LMDT12085L2026-08-18
20197344159014MEDLINEMDT12086XLMDT12086XL2026-08-18

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIR2026-06-26
06972164410022LOOKEE® AscleTrack™ Urine Microalbumin (MAU) Test StripKunming Lianen Biotechnology Co., LTDJIR2026-06-26
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIR2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIR2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIR2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIR2026-02-06
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.JIR2025-02-13
00850054026729QMedix™Diagnostic Automation, Inc.JIR2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIR2024-06-14
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIR2024-06-04
00630414631707Clinistix Kidney Health Test SystemSiemens Healthcare Diagnostics Inc.JIR2024-05-03
08806141303497One+Step 10ADFI CO.,LTDJIR2023-10-16
17290017272471Minuteful - kidney testHEALTHY.IO LTDJIR2022-11-01
10884389181973MedlineMEDLINE INDUSTRIES, INC.JIR2022-04-13