GUDIDData
Bulk Audit Tool API Access
Product Classification / EMDN Category

FDA Product Code: KQO

Directory of devices assigned to product classification code KQO.

classification Automated Urinalysis System Manufacturer:
View Specs →
gudid A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid AUTION EYE Calibrator is intended for in vitro diagnostic use only for focusing and calibrating the AUTION EYE AI-4510. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid AUTION EYE Control Solution H/L is intended for in vitro diagnostic use only for performing quality control procedures with the AUTION EYE AI-4510. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid AUTION EYE Sheath Solution is intended for in vitro diagnostic use with the AUTION EYE AI-4510 analyzer to identify formed particles in urine samples through flow cell cytometry. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid he AUTION HYBRID AU-4050 Fully Automated Integrated Urine Analyzer System contains a test strip chemistry urine analyzer and a flow cytometry urine particle analyzer together in a single integrated device. The test strip chemistry module (CHM) is an automated urine analyzer intended for the in vitro measurement of the following parameters: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, specific gravity, turbidity, and color. The chemistry module is intended for use with the Uriflet S 9HA multi-parameter urine chemistry test strips. The flow cytometry module (FCM) is an automated urine particle analyzer intended to analyze the following parameters in urine samples: Red Blood Cells, White Blood Cells, Epithelial Cells, Casts, and Bacteria and flags the presence of the following: Pathological Casts, Crystals, Sperm, Small Round Cells, Yeast Like Cells, and Mucus. The AUTION HYBRID AU-4050 is intended for in vitro diagnostic use in screening patient populations found in clinical laboratories. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid Urine Analyzer utilize reflectance technology with with AUTION Strips reagent to provide qualitative or semiquantitative urine chemistry results. Refractometery is used for specific gravity measurements, light transmission for color, and light scatter for turbidity. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid AUTION Sticks 9EB test strips are test strips for the in vitro qualitative or semi-quantitative measurement of the following analytes: glucose, protein, bilirubin, urobilinogen, pH, blood, ketones, nitrite, leukocytes, turbidity, and color. The test results of these parameters can be used in the evaluation of kidney, urinary, liver and other metabolic disorders. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid Dipstick reagent strips for the qualitative detection of the following : Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, and Nitrite in Urine. Manufacturer: GERMAINE LABORATORIES, INC
View Specs →
gudid Dipstick reagent strips for the qualitative detection of the following : Blood, Glucose, Protein, Ketone and pH in Urine. Manufacturer: GERMAINE LABORATORIES, INC
View Specs →
gudid Optional barcode reader for use with AimStrip Urine Analyzers. Manufacturer: GERMAINE LABORATORIES, INC
View Specs →
gudid The AimStrip Urine Analyzer / CT-120 Analyzer is intended for use in conjunction with the AimStrip Urine Reagent Strips. Manufacturer: GERMAINE LABORATORIES, INC
View Specs →
gudid AIMSTRIP URINE AUTO ANALYZER Manufacturer: GERMAINE LABORATORIES, INC
View Specs →
gudid Dipstick reagent strips for the qualitative detection of the following : Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in Urine. Manufacturer: GERMAINE LABORATORIES, INC
View Specs →
gudid Dipstick reagent strips for the qualitative detection of Glucose in Urine. Manufacturer: GERMAINE LABORATORIES, INC
View Specs →
gudid LOOKEE AscleTrack Urine Test Analyzer Manufacturer: Kunming Lianen Biotechnology Co., LTD
View Specs →
gudid HemoCue Albumin 201 Analyzer mg/L Manufacturer: Hemocue AB
View Specs →
gudid urine analyzer Manufacturer: Contec Medical Systems Co., Ltd.
View Specs →
gudid Pro Advantage Urine Strip Analyzer Manufacturer: NATIONAL DISTRIBUTION & CONTRACTING, INC.
View Specs →
gudid The Uri-Trak 120 Urine Analyzer is intended for use in conjunction with Stanbio Uri-Chek and Uri-Con 10 Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, and Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. Manufacturer: STANBIO LABORATORY, L.P.
View Specs →
gudid The Uri-Trak 120 Urine Analyzer is intended for use in conjunction with Stanbio Uri-Chek and Uri-Con 10 Urinalysis Reagent Strips for the semi-quantitative detection of the following analytes in urine: Glucose, Bilirubin, Ketone (Acetoacetic acid), Specific Gravity, Blood, pH, Protein, Urobilinogen, and Leukocytes, as well as the qualitative detection of Nitrite. The instrument is intended for professional, in vitro diagnostic use only. Manufacturer: STANBIO LABORATORY, L.P.
View Specs →
gudid Urine Analyzer 500 Manufacturer: BTNX Inc
View Specs →
gudid My Yodoc Manufacturer: S-CONNECT CO.,LTD
View Specs →
gudid HemoCue Urine Albumin Microcuvettes 2x25 single Manufacturer: Hemocue AB
View Specs →
gudid DxU 1800c Fully-Automated Urine Chemistry Analyzer Manufacturer: Beckman Coulter, Inc.
View Specs →
gudid Urinalysis Win10 Kit with PC7 hardware Manufacturer: BECKMAN COULTER IRELAND INC.
View Specs →
gudid The URiSCAN Optima urine chemistry test system consists of URiSCAN Optima Urine analyzer and URiSCAN urine test strips. The intended use of the URiSCAN Optima Urine analyzer is to read the color change on the test pads found on the URiSCAN urine test strips and to display and print the results. These measurements are useful in the evaluation of renal, urinary and metabolic disorders. Manufacturer: YD Diagnostics CORP.
View Specs →
gudid The CLINITEK Status Connector is intended for use with the CLINITEK Status+ analyzer. The connector allows network connectivity andcentralized control of all the satellite Point of Care (POC) Clinitek Status+ analyzers. The connector communicates with remote hospital and Laboratory Information Systems (HIS/LIS) and interfaces with Electronic Medical Records (EMR). Manufacturer: Siemens Healthcare Diagnostics Inc.
View Specs →
gudid Quality control for CLINITEK Atlas and CLINITEK Novus analyzers Manufacturer: Siemens Healthcare Diagnostics Inc.
View Specs →
gudid Quality control for CLINITEK Atlas and CLINITEK Novus analyzers Manufacturer: Siemens Healthcare Diagnostics Inc.
View Specs →
gudid Clinitek Atlas Calibration Kit. For use with CLINITEK ATLAS Automated Urine Chemistry System. Manufacturer: Siemens Healthcare Diagnostics Inc.
View Specs →
gudid Clinitek Atlas 10 Reagent PAK for Urine Chemistry for use with the Clinitek Atlas Urine Chemistry Analyzer Manufacturer: Siemens Healthcare Diagnostics Inc.
View Specs →
gudid Rinse additive, an in vitro diagnostics device for use on the CLINITEK Atlas automated urine chemistry system Manufacturer: Siemens Healthcare Diagnostics Inc.
View Specs →
gudid Clinitek Atlas Calibrator #4 In vitro diagnostic medical device Manufacturer: Siemens Healthcare Diagnostics Inc.
View Specs →
gudid cobas u 601 urine analyzer Manufacturer: Roche Diagnostics GmbH
View Specs →
gudid cobas u 411 Urine Analyzer Manufacturer: Roche Diagnostics GmbH
View Specs →
gudid Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid Consumable for the identification and enumeration of WBC, RBC, Casts, Epithelial Cells, and Bacteria as well as flags for pathologic casts, yeast, crystal, small round cells, mucus, and sperm in urine sediment. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid Test Sticks for the determination of Glucose, Protein, Bilirubin, Urobilinogen, pH, Blood, Ketones, Nitrite, Leukocytes in urine. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid A concentrated wash or cleaning solution intended to be used as a consumable reagent on-board an automated or semi-automated instrument that is used for the processing, staining and/or testing of clinical laboratory specimens. Manufacturer: ARKRAY USA, INC.
View Specs →
gudid Sciteck Manufacturer: Sciteck Diagnostics, Inc.
View Specs →
gudid The Rapid Response U121S Urine Analyzer is intended for use in conjunction with the Rapid Response Urinalysis Reagent Strips for the semi-quantitative detection of analytes in human urine. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. The instrument is intended for professional, in vitro diagnostic use only. Manufacturer: BTNX Inc
View Specs →
gudid The Rapid Response U120S Urine Analyzer is intended for use in conjunction with the Rapid Response Urinalysis Reagent Strips for the semi-quantitative detection of analytes in human urine. The measurement can be used in general evaluation of health, and aids in the diagnosis and monitoring of metabolic or systemic diseases that affect kidney function, endocrine disorders and diseases or disorders of the urinary tract. The instrument is intended for professional, in vitro diagnostic use only. Manufacturer: BTNX Inc
View Specs →
gudid "2.5 iChem Velocity Instrument Bring Up and Test; 800-7167 iChem VELOCITY Automated Urine Chemistry System w load/Unload (NA)""2.5 iChem Velocity Instrument Bring Up and Test; 800-7719 Stand-Alone Velocity (NA)" Manufacturer: BECKMAN COULTER IRELAND INC.
View Specs →
gudid AX-4280 Specific Gravity Calibrator Set Manufacturer: IRIS INTERNATIONAL, INC.
View Specs →
gudid iChem10 SG Urine Chemistry Strips Manufacturer: IRIS INTERNATIONAL, INC.
View Specs →
gudid 2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7720 Back-Integrated Velocity (NA)2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3530 Back Integrated Velocity Computerless System Ready (NA)"2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7106 COMPUTERLESS VELOCITY""2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-7190 IRICELL 1500 (NA)""2.5 iChem Velocity Instrument Computerless Bring Up and Test;800-3049 iRICELL 2000 Pro (NA)"2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7714 iRICELL 2000 Plus (NA)"2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-7713 iRICELL 3000 Plus (NA)""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3079 iRICELL 3000 Pro (NA) w load/unload""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3048 iRICELL 3000 Pro (NA)""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3080 iRICELL 3000 PRO w/ Load/Unload""2.5 iChem Velocity Instrument Computerless Bring Up and Test; 800-3050 iRICELL 1000 Pro (NA)" Manufacturer: BECKMAN COULTER IRELAND INC.
View Specs →
gudid "iQ200 Elite 2008 Tested;800-3934 iQ200 Elite Plus (US) (2008 Version) (NA);800-7714 IRICELL 2000 Plus (NA)" Manufacturer: BECKMAN COULTER IRELAND INC.
View Specs →
gudid "iQ200 Select 2008 Instrument; 800-7190 IRICELL 1500 (NA)""iQ200 Elite 2008 Tested; 800-3052 iQ200 Elite Pro (NA); 800-3049 IRICELL 2000 Pro (NA)" Manufacturer: BECKMAN COULTER IRELAND INC.
View Specs →
gudid "iQ200 Select 2008 Tested;800-3935 iQ200 Select Plus Kit 2008 Analyzer (NA)"iQ200 Select 2008 Tested; 800-3051 iQ200 Select Pro (NA); 800-3050 IRICELL 1000 Pro (NA); 800-3048 IRICELL 3000 Pro (NA)" Manufacturer: BECKMAN COULTER IRELAND INC.
View Specs →
gudid "iQ200 Sprint 2008 Tested; 800-3053 iQ200 Sprint Pro (NA)""iQ200 Sprint 2008 Tested; 800-3081 iQ200 SPRINT w load/unload (NA);""iQ200 Sprint 2008 Tested; 800-3082 iQ200 SPRINT Pro w load/unload (NA); 800-3080 IRICELL 3000 PRO w load/unload; 800-3048 IRICELL 3000 Pro (NA)""iQ200 Sprint 2008 Tested; 800-3933 iQ200 Sprint Plus US (2008 Version) (NA); 800-7713 IRICELL 3000 Plus (NA);800-3079 IRICELL 3000 Plus w/ Load Unload (NA)" Manufacturer: BECKMAN COULTER IRELAND INC.
View Specs →
gudid Semi-Auto Urine AnalyzerFor UrineLight Weight Compact DesignFull Duplex Communication InterfaceInternal/external Printer InterfaceEasy CleaningDisplay in 8 LanguagesUAREADER2 Manufacturer: Cardinal Health 200, LLC
View Specs →
gudid Teco Diagnostics Uritek TC-201 Urine Chemistry Test System consists of the Uritek TC-201 Urine Chemistry Analyzer and the Teco Diagnostics Urine Reagent (URS-10) Strips. The Uritek TC-201 urine analyzer is an automated, bench top instrument which is intended for point-of-care, in vitro diagnostic use only and is intended to be used together with the Teco Diagnostics Urine Reagent (URS-10) Strips as a system for semi-quantitative detection of Glucose, Bilirubin, Ketone, Specific Gravity, Blood, pH, Protein, Urobilinogen, Nitrite and Leukocytes in urine. These measurements are used to aid in the diagnosis of metabolic disorders, kidney function anomalies, urinary tract infections and liver function. Manufacturer: TECO DIAGNOSTICS
View Specs →
gudid URINE ANALYZER with Barcode Reader Manufacturer: Acon Laboratories, Inc.
View Specs →
gudid URINE ANALYZER Manufacturer: Acon Laboratories, Inc.
View Specs →
gudid Mission U120 Urine Analyzer with Barcode Reader Manufacturer: Acon Laboratories, Inc.
View Specs →
gudid Mission U120 Urine Analyzer Manufacturer: Acon Laboratories, Inc.
View Specs →