Advanced Instruments, LLC

FDA Registration(s)#

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

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Registered Device Listings#

Product Codes Associated With Registrations#

GUDID#

• Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Used for aspirating and dispensing sample and reagents.

  Advanced Instruments, LLC

  2016-09-23

• Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Used for aspirating and dispensing sample and reagents.

  Advanced Instruments, LLC

  2016-09-23

• Advanced Instruments GloCyte® Vacuum Preparation Station Assembly - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Vacuum Station has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Accelerates the capturing of stained cells on the test cartridge.

  Advanced Instruments, LLC

  2016-09-23

• Advanced Instruments GloCyte® Controls Kit - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Low and High Level Control Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains one 3mL vial of Low Level Control and one 3mL vial of High Level Control.

  Advanced Instruments, LLC

  2016-09-23

• Advanced Instruments GloCyte® Count Template Cartridge - For In Vitro Diagnostic Use. Advanced Instruments GloCyte Count Template Cartridge has been developed for use exclusively with the Advanced Instruments GloCyte Automated Cell Counter System. The Count Template Cartridge is a service tool used to check the performance of the GloCyte System.

  Advanced Instruments, LLC

  2016-09-23

• Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments Clinitrol 290 Reference Solution - 2mL Ampule - Pkg 10 - Clinitrol 290 Reference Solution is intended for use in evaluating the performance of customer osmometers. It is a true reference designed specifically for osmometers and provides results that approximat the osmolality of normal serum.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments 850 mOsm Calibration Standard - 2mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments A2O Advanced Automated Osmometer Samples Tubes, Box of 500 - Sample tubes for use with the A2O Advanced Automated Osmometer

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments 200 mOsm Calibration Standard - 2mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments 400 mOsm Calibration Standard - 2mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments 1000 mOsm Calibration Standard - 2mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments 4000 mOsm Calibration Std - 2mL Ampule - Pkg 10 - 3MA400

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments OsmoPRO Multi Sample Micro Osmometer Sample Tubes - Samples tubes for use with the OsmoPRO® Multi-Sample Micro-Osmometer

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments 300 mOsm Calibration Std - 2mL Ampule - Pkg 10 - 3MA003

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments GloCyte® Total Nucleated Cell Test Reagent Kit - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Total Nucleated Cell Reagent Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains three 1.8mL vials of Total Nucleated Cell (TNC) Reagent.

  Advanced Instruments, LLC

  2016-09-23

• Advanced Instruments Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 8 - Renol urine osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls may be used daily to monitor the precision of the testing procedure for osmolality, and to conduct laboratory proficiency testing. Renol urine controls are formulated to mimic reportable ranges (low-to-high levels) for urine.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9 - Protinol protein-based osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls may be used daily to monitor the precision of the testing procedure for osmolality, and to conduct laboratory proficiency testing. Protinol protein-based controls are formulated to mimic reportable ranges (low-to-high levels) for human serum.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10 - The Osmolality Linearity Set is designed to help clinical laboratories easily monitor osmometer performance specifications and fulfill CLIA requirements for verifying the reportable range of a laboratory method.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments Osmo1® Single-Sample Micro-Osmometer - With the Osmo1 Single-Sample Micro-Osmometer, we’ve bundled together accurate and reliable osmolality measurement with ease-of-use for efficient patient sample analysis. Easily maintain regulatory compliance while ensuring the security and integrity of patient data with the Osmo1. Best for labs that process 10 or fewer samples per day or prefer a direct-draw instrument.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer - Supporting efficient workflows for mid- to high-volume clinical chemistry labs, the OsmoPRO features a convenient carousel design that handles up to 20 samples, an intuitive touchscreen interface, and industry-leading performance. Simple, reliable, and efficient, the OsmoPRO delivers accurate and precise analysis of patient samples for maximum productivity.

  Advanced Instruments, LLC

  2020-09-21

• A20 Advanced Automated Osmometer - Built to keep the busiest labs productive, the A2O Advanced Automated Osmometer combines exceptional analytical performance with full automation. Laboratories can depend on the A2O to deliver accurate and precise osmolality measurements while maximizing walk-away time.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments Heat Transfer Fluid - Heat Transfer Fluid is used in specific single-sample osmometers to facilitate the thermodynamic processes necessary for measuring osmolality.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments 100 mOsm Calibration Standard - 110 mL Bottle - Calibration standards are used to calibrate and/or check the performance of customer osmometers.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments Fiske 210 Single-Sample Micro-Osmometer Sample Tubes, Box - Sample tubes and cleaners for use with the Fiske™ 210 Single-Sample Micro-Osmometer

  Advanced Instruments, LLC

  2020-09-21

• Fiske 210 Single-Sample Micro-Osmometer - The Fiske 210 Single-Sample Micro-Osmometer is designed for routine osmolality measurement in clinical, pharma, biotech, and food and beverage labs. Providing accurate and precise osmolality measurement, with an operating range of 0-2000 mOsm.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments Model 3250 Single-Sample Osmometer - The Advanced Instruments 3250 Single-Sample Osmometer is designed for routine osmolality measurement in pharma, biotech, and food and beverage labs. Providing accurate and precise osmolality measurement, with an operating range of 0-4000 mOsm.

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments Bin Setting Fluid – 10 mL - Bin-Setting Fluid (10 mL ampoule) for use with select Advanced Instruments' instruments

  Advanced Instruments, LLC

  2020-09-21

• Advanced Instruments GloCyte® Test Cartridge & Tray - 25 Cartridges - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Tray - 25 Cartridges has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains 25 test cartridges.

  Advanced Instruments, LLC

  2016-09-23

• Advanced Instruments Microsample Test Kit, Plunger Wire, 500 Tips/Cleaners - For In vitro diagnostic use. The Advanced™ Micro-Sample Test Kit conveniently supplies the consumables needed for osmolality testing: 500 sampler tips, 500 chamber cleaners, and one replacement plunger wire.

  Advanced Instruments, LLC

  2019-03-22

• Advanced Instruments GloCyte® Automated Cell Counter System - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Automated Cell Counter System is intended for use by trained healthcare professionals in clinical laboratories to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid collected from adult and pediatric patients. Includes GloCyte instrument, computer, vacuum station, barcode reader, sample preparation tray, pipettes, and startup kit.

  Advanced Instruments, LLC

  2016-09-23

• Advanced Instruments GloCyte® Instrument Assembly - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Instrument has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Utilizes fluorescence-based technology to provide quantitative determination of fluorescence labeled total nucleated cells and erythrocytes in cerebrospinal fluid.

  Advanced Instruments, LLC

  2016-09-23

• Advanced Instruments GloCyte® Low Level Control Vial (Single) - 3 mL vial of Low Level Control

  Advanced Instruments, LLC

  2016-09-23

• Advanced Instruments GloCyte® High Level Control Vial (Single) - 3 mL vial of High Level Control

  Advanced Instruments, LLC

  2016-09-23

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