novabio.comGlocyte Automated Cell Counter System
Advanced Instruments, Inc.
Advanced Instruments, LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 1217058 | 1217058 | Advanced Instruments, LLC | 1 | N | 2026-01-01 | 2 Technology Way NORWOOD MA US 02062 |
| 1221020 | 1221020 | Advanced Instruments, LLC | 1 | N | 2026-01-01 | 25 BRADLEY DR. WESTBROOK ME US 04092 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00816068020009 | 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. | +1-781-894-0800 | info@novabio.com |
| 00816068020016 | 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. | +1-781-894-0800 | info@novabio.com |
| 00816068020153 | 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. | +1-781-894-0800 | info@novabio.com |
| 00816068020535 | Advanced Instruments RBC Reagent Filtration Kit - The RBC Reagent Filtration Kit is used for filtering the RBC Reagent when diluent and reagent counts exceed the acceptance criteria | +1-781-894-0800 | info@novabio.com |
| 00816068020856 | Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit - Multilevel control that provides a means of measuring and verifying the performance of the GloCyte Cell counter for CSF for total nucleated and red blood cells. | +1-781-894-0800 | info@novabio.com |
| 10816068020174 | Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene - Contains 960 1-200µL pipette tips | +1-781-894-0800 | info@novabio.com |
| 10816068020211 | Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit - The GloCyte Red Blood Cell (RBC) Reagent is a non-automated in-vitro diagnostic device intended to stain erythrocytes for quantitative enumeration of RBCs in human cerebrospinal fluid (CSF) specimens collected from adult and pediatric patients. The reagent is intended to be used by trained healthcare professionals in clinical laboratories as an aid in diagnosis for neurological diseases such as a meningeal infection, subarachnoid hemorrhage, central nervous system malignancy, and demyelinating disease. For use on the GloCyte Automated Cell Counter System only. | +1-781-894-0800 | info@novabio.com |
| 20816068020201 | Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains 200 test cartridges. | +1-781-894-0800 | info@novabio.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 29942 | 1663348799 | K790608 | BL BILIRUBINOMETER | CIG | 1979-06-15 |
| 29942 | 1571762573 | K152776 | Glocyte Automated Cell Counter System | GKL | 2016-05-27 |
| 29942 | 1171503784 | ||||
| 29942 | 1184180033 | ||||
| 29942 | 1186846897 | ||||
| 29942 | 1558992027 | ||||
| 29942 | 1596665306 | ||||
| 322018 | 1683147123 |
Product Codes Associated With Registrations#
PMN#
PATIENT MONITOR
ADVANCED INSTRUMENTS, INC.
VITAL SIGNS MONITOR
ADVANCED INSTRUMENTS, INC.
THE ADVANCED OSMOMETER (3900)
ADVANCED INSTRUMENTS, INC.
ADVANCED MICRO-OSMOMETER MODEL 3300
ADVANCED INSTRUMENTS, INC.
INTERMITTENT COMPRESSION SYSTEM MODEL 5000
ADVANCED INSTRUMENTS, INC.
MODEL 3D3 OSMOMETER
ADVANCED INSTRUMENTS, INC.
OSMOMETER MODEL 2400
ADVANCED INSTRUMENTS, INC.
OSMOMETER MODEL 110
ADVANCED INSTRUMENTS, INC.
ELECTRONIC METAL LOCATOR MODEL MD-1
ADVANCED INSTRUMENTS, INC.
CEREGROTRAC
ADVANCED INSTRUMENTS, INC.
VIDEO PRINT
ADVANCED INSTRUMENTS, INC.
MICRO-SAMPLE OSMOMETER 3M0
ADVANCED INSTRUMENTS, INC.
BILIRUBINOMETER
ADVANCED INSTRUMENTS, INC.
BL BILIRUBINOMETER
ADVANCED INSTRUMENTS, INC.
OSMOMETER MODEL 3W11
ADVANCED INSTRUMENTS, INC.
GUDID#
Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene - Contains 960 1-200µL pipette tips
2016-09-23
Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit - The GloCyte Red Blood Cell (RBC) Reagent is a non-automated in-vitro diagnostic device intended to stain erythrocytes for quantitative enumeration of RBCs in human cerebrospinal fluid (CSF) specimens collected from adult and pediatric patients. The reagent is intended to be used by trained healthcare professionals in clinical laboratories as an aid in diagnosis for neurological diseases such as a meningeal infection, subarachnoid hemorrhage, central nervous system malignancy, and demyelinating disease. For use on the GloCyte Automated Cell Counter System only.
2016-09-23
Advanced Instruments RBC Reagent Filtration Kit - The RBC Reagent Filtration Kit is used for filtering the RBC Reagent when diluent and reagent counts exceed the acceptance criteria
2021-05-21
Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit - Multilevel control that provides a means of measuring and verifying the performance of the GloCyte Cell counter for CSF for total nucleated and red blood cells.
2020-07-21
Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays - For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains 200 test cartridges.
2016-09-23
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.
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.
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.
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.
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.
2016-09-23
Advanced Instruments Clinitrol 290 Reference Solution, 5mL 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.
2020-09-21
Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.
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.
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.
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.
2020-09-21
Advanced Instruments 100 mOsm Calibration Standard - 5mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.
2020-09-21
Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.
2020-09-21
Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.
2020-09-21
Advanced Instruments 900 mOsm Calibration Standard - 5mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.
2020-09-21
Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.
2020-09-21
Advanced Instruments A2O Advanced Automated Osmometer Samples Tubes, Box of 500 - Sample tubes for use with the A2O Advanced Automated Osmometer
2020-09-21
Advanced Instruments 3000 mOsm Calibration Standard - 5mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.
2020-09-21
Advanced Instruments 0 mOsm Calibration Standard - 2mL Ampule - Pkg 10 - Calibration standards are used to calibrate and/or check the performance of customer osmometers.
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.
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.
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.
2020-09-21
Advanced Instruments 4000 mOsm Calibration Std - 2mL Ampule - Pkg 10 - 3MA400
2020-09-21
Advanced Instruments OsmoPRO Multi Sample Micro Osmometer Sample Tubes - Samples tubes for use with the OsmoPRO® Multi-Sample Micro-Osmometer
2020-09-21
Advanced Instruments Model 3250 Single-Sample Osmometer Sample Tubes, Box of 500 - Sample tubes for use with the Model 3250 Single-Sample Osmometer
2020-09-21
Advanced Instruments 300 mOsm Calibration Std - 2mL Ampule - Pkg 10 - 3MA003
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.
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.
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.
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.
2020-09-21
Advanced Instruments Ease-Eject 20-Microliter Sampler - Advanced Instruments Ease-Eject 20-Microliter Sampler for use with Advanced Instruments Osmo1® Single-Sample Micro-Osmometer or Advanced Instruments OsmoTECH® Single-Sample Micro-Osmometer
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.
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.
2020-09-21
Advanced Instruments 2020 Osmometer Probe Wiper Rings - Advanced Instruments probe wiper rings are used to mitigate sample carry-over during osmolality testing
2020-09-21
Advanced Instruments 20 µL Pipet - Advanced Instruments pipettes are used to facilitate sample management while using Advanced Instruments osmometers
2020-09-21
Advanced Instruments A2O Osmometer Probe Wiper Rings - Advanced Instruments probe wiper rings are used to mitigate sample carry-over during osmolality testing
2020-09-21