FDA.reportPublic FDA data

Medline

Primary DI
10888277110403
Brand
Medline
Company
MEDLINE INDUSTRIES, INC.
Model
MPHUA2GP
Catalog number
MPHUA2GP
Device description
STRIPS,URINE,REAGENT,2GP,100 STRIPS/BT
Published
2020-08-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JMTDIAZO (COLORIMETRIC), NITRITE (URINARY, NON-QUANT)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JMTDiazo (Colorimetric), Nitrite (Urinary, Non-Quant)Clinical Chemistry1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10888277110403PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088827711040310888277110403

GMDN Terms#

Term, Definition table
TermDefinition
Multiple urine analyte IVD, kit, colorimetric dipstick, rapidA collection of reagents and other associated materials intended to be used for the qualitative and/or semi-quantitative screening of urine for multiple analytes within a short period relative to standard laboratory testing procedures, using a colorimetric dipstick method. This test is commonly used in the laboratory or in point-of-care analyses.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
025460908
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10653160393306MEDLINEDYND74299DYND742992026-05-26
10080196031214MEDLINEDYND13515DYND135152021-02-19
10080196032143MEDLINEDYND30331DYND303312022-03-29
10080196137695MEDLINEDYND30351DYND303512021-11-02
10080196158522MEDLINEMDS138000MDS1380002021-05-14
10080196258598MEDLINEMDT013020457MDT0130204572016-10-14
10080196260126MEDLINEMDT013628MDT0136282016-10-14
10080196363773MEDLINEMDT013667MDT0136672016-10-14
10080196363803MEDLINEMDT013673FMDT013673F2016-10-14
10197344039746MEDLINEHNX19100HNX191002024-10-11
10197344039784MEDLINEHNX20150HNX201502024-10-11
10197344039838MEDLINEHNY19100HNY191002024-10-11
10197344039845MEDLINEHNY19150HNY191502024-10-11
10197344039852MEDLINEHNY20075HNY200752024-10-11
10197344039869MEDLINEHNY20100HNY201002024-10-11
10197344039876MEDLINEHNY20150HNY201502024-10-11
10197344039883MEDLINEHNY22075HNY220752024-10-11
10197344039890MEDLINEHNY22100HNY221002024-10-11
10197344039906MEDLINEHNY22150HNY221502024-09-27
10197344099771MEDLINEAVT0665AVT06652025-03-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810164510624Atida Urinary Tract Infection TestACESO LABORATORIES INC.JMT2026-03-23
10860011489129Vivoo At-Home UTI Test StripsVIVOSENS INC.JMT2026-02-13
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JMT2026-02-06
04987486053002S.G. Calibrator HARKRAY USA, INC.JMT2025-12-19
00860011489146Vivoo At-Home Urinary Tract Infection TestVIVOSENS INC.JMT2024-11-25
20682607651256HealthyMe UTI Urinary Tract Infection Test StripsACON LABORATORIES, INC.JMT2024-03-27
00630414317427Clinistix UTI Test StripsSiemens Healthcare Diagnostics Inc.JMT2024-02-21
10810143620006GenaCheck Rapid Self-Test Kit For Urinary Tract InfectionsGenabio Diagnostics Inc.JMT2023-10-06
00860010249000Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
00860010249017Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
00860010249024Starling Medical, IncStarling Medical, Inc.JMT2023-05-22
50885380175549CARDINAL HEALTHCardinal Health 200, LLCJMT2020-06-30
50096295135850LEADERCARDINAL HEALTH, INC.JMT2019-04-18
04987486001959S.G. Calibrator HARKRAY USA, INC.JMT2017-04-12
10673486000405TECO DIAGNOSTICSTECO DIAGNOSTICSJMT2017-01-05
10673486000382TECO DIAGNOSTICSTECO DIAGNOSTICSJMT2017-01-05
10673486000399TECO DIAGNOSTICSTECO DIAGNOSTICSJMT2017-01-05
00722066003404Rapid ResponseBTNX IncJMT2016-10-25
00722066000373Rapid ResponseBTNX IncJMT2016-10-17
10763924410146AccutestJANT PHARMACAL CORPORATIONJMT2016-09-24
00682607000401Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
00682607000678Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
00682607000685Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
20682607200133Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
20682607200225Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
20682607200317Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
20682607200324Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
20682607200331Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
20682607200362Mission Urinalysis Reagent StripsACON LABORATORIES, INC.JMT2016-09-24
00630414549033Multistix® 8 SG Reagent StripsSiemens Healthcare Diagnostics Inc.JMT2016-09-24