FDA.reportPublic FDA data

Mission Urinalysis Reagent Strips

Primary DI
00682607200085
Brand
Mission Urinalysis Reagent Strips
Company
Acon Laboratories, Inc.
Model
U031-011
Device description
Mission Urinalysis Reagent Strips (GLU)
Published
2016-09-24
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
JILMETHOD, ENZYMATIC, GLUCOSE (URINARY, NON-QUANTITATIVE)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JILMethod, Enzymatic, Glucose (Urinary, Non-Quantitative)Clinical Chemistry2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20682607200089PackageGS112In Commercial Distribution
00682607200085PrimaryGS10
00682607000715Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2068260720008920682607200089
00682607200085006826072000856826072000850682607200085
00682607000715006826070007156826070007150682607000715

GMDN Terms#

Term, Definition table
TermDefinition
Urine glucose IVD, kit, rapid colorimetric, clinicalA collection of reagents and other associated materials intended to be used for the qualitative and/or (semi-)quantitative screening of urine for glucose 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 aid clinicians in the diagnosis and monitoring of diabetes. 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
Special Storage Condition, Specify00Store in a cool, dry place
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Contacts#

Phone, Email table
PhoneEmail
+1(800)838-9502support@aconlabs.com

Regulatory Flags#

DUNS number
781100966
Device count
100
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00682607541072On Call Lancets (33G)G124-10AG124-10A2026-03-30
00682607541065On Call Lancing DeviceG124-11AG124-11A2026-03-18
00682607690053Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TC131-2041C131-20412026-03-09
00682607690077Mission Cholesterol Optical Check DeviceC121-2021C121-20212026-03-09
00682607690084Mission Cholesterol Control SolutionC121-2011C121-20112026-03-09
00682607690091Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TC131-2041C131-20412026-03-09
10682607690050Mission Cholesterol Test Device - 3-in-1 Lipid Panel 25TC131-2041C131-20412026-03-09
00682607690060Mission Cholesterol MeterC111-2021C111-20212026-03-09
10682607690074Mission Cholesterol Optical Check DeviceC121-2021C121-20212026-03-09
10682607690081Mission Cholesterol Control SolutionC121-2011C121-20112026-03-09
10682607690098Mission Cholesterol Test Device - 3-in-1 Lipid Panel 5TC131-2041C131-20412026-03-09
00682607541058On Call Lancets 30GG124-10AG124-10A2026-02-19
10682607541055On Call Lancets 30GG124-10AG124-10A2026-02-19
20682607200485Mission U120 Smart Urine AnalyzerU117-1012026-02-06
20682607200492Mission U120 Smart Urine AnalyzerU117-1112026-02-06
20682607200904Mission U120 Touch Urine AnalyzerU119-106-1012026-02-06
20682607200911Mission U120 Touch Urine AnalyzerU119-116-1012026-02-06
00682607541829On Call Stealth Lancing DeviceG124-18AG124-18A2026-02-03
20682607541823On Call Stealth Lancing DeviceG124-18AG124-18A2026-02-03
00810107290002Flowflex Plus COVID-19 + Flu A/B Home TestL03A-R0645, L03A-R0745, L03A-R0845, L03A-R0945L03A-R0645, L03A-R0745, L03A-R0845, L03A-R09452026-01-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06935740751773Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751780URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751797URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751803Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751810Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751827URINE REAGENT STRIPSUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751834Urine StripsUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.JIL2026-06-03
06935740750608Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIL2026-04-16
06935740750615Urine Reagent StripsUrit Medical Electronic Co., Ltd.JIL2026-04-16
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-04-16
20682607200485Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200492Mission U120 Smart Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200904Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
20682607200911Mission U120 Touch Urine AnalyzerAcon Laboratories, Inc.JIL2026-02-06
00015482104658AUTION MAX™ AX-4060 AnalyzerARKRAY USA, INC.JIL2025-11-07
10612479279886MckessonMCKESSON MEDICAL-SURGICAL INC.JIL2025-09-18
00015482117313AUTION MAX™ AX-4060 AnalyzerARKRAY USA, INC.JIL2024-12-02
00850054026729QMedix™Diagnostic Automation, Inc.JIL2024-10-29
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.JIL2024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSJIL2024-06-06
10673486000498Teco Diagnostics Uritek TC-720+ Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-05
10673486000511Teco Diagnostics Uritek TC-201 Urine Chemistry Test SystemTECO DIAGNOSTICSJIL2024-06-04
10673486002416Teco Diagnostics Urine Reagent Strips (URS-1G)TECO DIAGNOSTICSJIL2024-03-22
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.JIL2023-06-08
10888277720336MedlineMEDLINE INDUSTRIES, INC.JIL2022-12-10
10884389181966MedlineMEDLINE INDUSTRIES, INC.JIL2022-10-28