FDA.reportPublic FDA data

Mission U120 Touch Urine Analyzer

Primary DI
20682607200911
Brand
Mission U120 Touch Urine Analyzer
Company
Acon Laboratories, Inc.
Model
U119-116-101
Device description
URINE ANALYZER with Barcode Reader
Published
2026-02-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
CDMDIAZONIUM COLORIMETRY, UROBILINOGEN (URINARY, NON-QUANT.)
CENDye-indicator, pH (urinary, non-quantitative)
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.)
JJBAZO-DYES, COLORIMETRIC, BILIRUBIN & ITS CONJUGATES (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
CDMDiazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.)Clinical Chemistry1
CENDye-Indicator, Ph (Urinary, Non-Quantitative)Clinical Chemistry1
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
JJBAzo-Dyes, Colorimetric, Bilirubin & Its Conjugates (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
20682607200911PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2068260720091120682607200911

GMDN Terms#

Term, Definition table
TermDefinition
Urine analyser IVD, point-of-careA mains electricity (AC-powered) instrument intended to be used by health professionals at the point-of-care for the qualitative and/or quantitative in vitro determination of various chemical and cellular constituents of a clinical urine specimen, which typically include bilirubin, glucose, haemoglobin, ketones, nitrites, pH, protein, urobilinogen, specific gravity, blood, red cells, white cells, casts, crystals, sperm, and/or microorganisms (e.g., bacteria). The device uses technology which may include electrical impedance, conductivity, enzyme spectrophotometry, nephelometry and/or photometry.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature36 Degrees Fahrenheit86 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
781100966
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00682607551385ON CALL® SURE BLOOD CONTROL SOLUTIONOGS-211G125-22U-1012026-07-30
00682607551392ON CALL® SURE BLOOD GLUCOSE MONITORING SYSTEMOGM-211G115-20U-1012026-07-30
00682607551408ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-21U-1012026-07-30
00682607551422ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-22U-1012026-07-30
00682607551439ON CALL® SURE BLOOD GLUCOSE METEROGM-211G115-23U-1012026-07-30
00682607551446ON CALL® SURE SYNC BLOOD GLUCOSE MONITORING SYSTEMOGM-212G115-20W-1012026-07-30
00682607551453ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-21W-1012026-07-30
00682607551460ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-22W-1012026-07-30
00682607551477ON CALL® SURE SYNC BLOOD GLUCOSE METEROGM-212G115-23W-1012026-07-30
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMOGM-511GK115-201-1012026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METEROGM-511GK115-221-1012026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMOGM-512GK115-222-1012026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONOGC-511GK125-221-1012026-07-30
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00682607815098ON CALL® SURE GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.JIN2026-07-30
00682607815104ON CALL® SURE GK BLOOD GLUCOSE & KETONE METERAcon Laboratories, Inc.JIN2026-07-30
00682607815111ON CALL® SURE SYNC GK BLOOD GLUCOSE & KETONE MONITORING SYSTEMAcon Laboratories, Inc.JIN2026-07-30
00682607815272ON CALL® SURE KETONE CONTROL SOLUTIONAcon Laboratories, Inc.JIN2026-07-30
00860015091604KetoBMKETOBM USA LLCJIN2026-07-14
00860015091628KetoBMKETOBM USA LLCJIN2026-07-14
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.CEN2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JFY2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.CDM2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIL2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIN2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.KQO2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIR2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JJB2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JMT2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.LJX2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JRE2026-06-26
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.JIO2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JJB2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIO2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.CDM2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.CEN2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JFY2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIL2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.KQO2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIN2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JIR2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.LJX2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JMT2026-06-26
06935740751575Urine Chemistry StripsUrit Medical Electronic Co., Ltd.JRE2026-06-26