FDA.reportPublic FDA data

Urine analyser IVD, laboratory

Definition
An electrically-powered automated or semi-automated laboratory instrument intended to be used 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.
GUDID devices
51
Last updated
2026-08-28 10:21:06

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00015482104658AUTION MAX™ AX-4060 AnalyzerArkray USA, Inc.1005262025-11-07
00015482117313AUTION MAX™ AX-4060 AnalyzerArkray USA, Inc.1107322024-12-02
00015482117344AUTION™ Sticks 9EB - Test StripsArkray USA, Inc.1107342024-12-02
00015482145057AUTION™ MAX AX-4030 AnalyzerArkray USA, Inc.145052016-09-23
00015482181550AUTION EYE™ Sheath Solution - 10L BottleArkray USA, Inc.1081552024-12-02
00015482181574AUTION EYE™ Control Solution H/LArkray USA, Inc.1081572024-12-02
00015482181598AUTION EYE™ Calibrator Focus/CalibratorArkray USA, Inc.1081592024-12-02
00015482188627AUTION EYE™ AI-4510 AnalyzerArkray USA, Inc.1088612024-12-02
00015482736279AUTION™ Sticks 9EB Test StripsArkray USA, Inc.736272016-09-23
04987486001959S.G. Calibrator HArkray USA, Inc.1006722017-04-12
04987486053002S.G. Calibrator HArkray USA, Inc.1115812025-12-19
04987486735212AUTION™ Uriflet 9HA Test StripsArkray USA, Inc.735212016-09-23
04987486738077AUTION™ Diluent SEDArkray USA, Inc.738072016-09-23
04987486738084AUTION™ Diluent BACArkray USA, Inc.738082016-09-23
04987486738091AUTION™ Staining Solution SEDArkray USA, Inc.738092016-09-23
04987486738107AUTION™ Staining Solution BACArkray USA, Inc.738102016-09-23
04987486738114AUTION™ Sheath SolutionArkray USA, Inc.738112016-09-23
06935740751568Fully-Automated Urine Chemistry AnalyzerUrit Medical Electronic Co., Ltd.DxU 1800c,1 unit2026-06-26
06972164410008LOOKEE® AscleTrack™ Urine Test AnalyzerKunming Lianen Biotechnology Co., LTDA802026-06-26
06935740751841Urine AnalyzerUrit Medical Electronic Co., Ltd.HTI CL-50 Plus2026-06-03
06935740751858Urine AnalyzerUrit Medical Electronic Co., Ltd.HTI CL-5002026-06-03
06935740751865URINE ANALYZERUrit Medical Electronic Co., Ltd.URITEST-500B2026-06-03
06935740751872URINE ANALYZERUrit Medical Electronic Co., Ltd.URITEST-502026-06-03
06935740750738Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.UC-18002026-04-16
20612479183678McKessonMCKESSON MEDICAL-SURGICAL INC.121-PP2020-03-13
20612479183685McKessonMCKESSON MEDICAL-SURGICAL INC.121-DTC2020-03-13
20612479183692McKessonMCKESSON MEDICAL-SURGICAL INC.121-BR2020-03-13
20612479197194McKessonMCKESSON MEDICAL-SURGICAL INC.121-PNS2020-03-13
06935740733755Automatic Urine AnalyzerUrit Medical Electronic Co., Ltd.UC-18002024-06-14
10673486000528Teco Diagnostics TC-Thunderbolt Automated Urine Analyzer SystemTECO DIAGNOSTICSTC-Thunderbolt2024-06-06
06936895301677BIOBASEBiobase Biodustry(Shandong)Co., Ltd.UA-3102023-07-05
06936895301684BIOBASEBiobase Biodustry(Shandong)Co., Ltd.UA-5102023-07-05
00657498002094Uri-Trak 120 M Urine AnalyzerSTANBIO LABORATORY, L.P.G1300-0012023-06-08
00810123204519Adler Instrument CompanyAdler, Inc.30-11562023-03-07
08056040140291ALFRED 60ALIFAX SRLALFRED 602022-10-06
08056040140307HB&L UROQUATTROALIFAX SRLHB&L UROQUATTRO2022-10-06
08056040140352ALFRED 60/ASTALIFAX SRLALFRED 60/AST2022-10-06
08056040141502HB&L UROQUATTRO LIGHTALIFAX SRLHB&L UROQUATTRO LIGHT2022-10-06
04015630946426Urisys 1100 Urine AnalyzerRoche Diagnostics GmbH77902280012016-09-20
10607415001294Moore MedicalMOORE MEDICAL LLC137862016-12-09
10607415002055Moore MedicalMOORE MEDICAL LLC306442016-12-09
10607415002062Moore MedicalMOORE MEDICAL LLC306492016-12-09
10837461001256iQ200BECKMAN COULTER IRELAND INC.Sprint Pro (NA)/SPRINT w load/unload (NA)/SPRINT P2016-09-07
10837461001300iQ200BECKMAN COULTER IRELAND INC.Select Plus Kit 2008 Analyzer (NA)/ Select Pro (N2016-09-07
10837461001317iQ200BECKMAN COULTER IRELAND INC.Select/Elite Pro (NA)2016-09-07
10837461001355iQ200BECKMAN COULTER IRELAND INC.Elite Plus (US) (2008 Version) (NA)2016-09-07
10837461001751iChem VelocityBECKMAN COULTER IRELAND INC.Back-Integrated Velocity (NA)2016-09-07
10837461002192iQ®200 IRIS INTERNATIONAL, INC.iQ® Lamina™ Cradle2016-09-07
10837461002529iChemIRIS INTERNATIONAL, INC.iChem®10SG Urine Chemistry Strips2016-09-07
10837461002628iChem® VELOCITY™BECKMAN COULTER IRELAND INC.iChem VELOCITY Urine Chemistry Strips2016-09-07
10837461009375iChem VelocityBECKMAN COULTER IRELAND INC.Elite/Stand-Alone Velocity (NA)2016-09-07