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 | |
|---|---|---|---|
| 00816068020047 | Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and Cuvettes - For In Vitro Diagnostic Use. Advanced Instruments Total and Direct Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma. Includes four 30mL bottles of Diluent, one 3mL bottle of 5mg/dL Bilirubin Equivalent, one bottle of 20mg/dL 3mL Bilirubin Equivalent, one 25mL bottle of Sulfanilic Acid Solution, one 25mL bottle of 0.2N Hydrochloric Acid, one 50mg Sodium Nitrite Tablet and 100 Cuvettes. | +1-781-894-0800 | info@novabio.com |
| 00816068020054 | Advanced Instruments BR2 Bilirubin Stat-Analyzer - For In Vitro Diagnostic Use. Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma. | +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 BR2 Hydrochloric Acid - 25mL bottle of Hydrochloric Acid
2016-09-23
Advanced Instruments BR2 Sulfanilic Acid - 25mL bottle of Sulfanilic Acid
2016-09-23
Advanced Instruments BR2 Sodium Nitrite - 50mg Sodium Nitrite Tablet
2016-09-23
Advanced Instruments BR2 5mg/dL Bilirubin Equivalent Solution - 3mL bottle of 5 mg/dL Bilirubin Equivalent Solution
2016-09-23
Advanced Instruments BR2 20 mg/dL Bilirubin Equivalent Solution - 3mL bottle of 20 mg/dL Bilirubin Equivalent Solution
2016-09-23
Advanced Instruments BR2 Sample Diluent - 30mL bottle of Diluent
2016-09-23
Advanced Instruments BR2 Bilirubin Stat-Analyzer - For In Vitro Diagnostic Use. Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma.
2016-09-23
Advanced Instruments BR2 Total and Direct Test Kit, Reagents, and Cuvettes - For In Vitro Diagnostic Use. Advanced Instruments Total and Direct Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) and DIRECT (DBR) bilirubin in neonatal serum or plasma. Includes four 30mL bottles of Diluent, one 3mL bottle of 5mg/dL Bilirubin Equivalent, one bottle of 20mg/dL 3mL Bilirubin Equivalent, one 25mL bottle of Sulfanilic Acid Solution, one 25mL bottle of 0.2N Hydrochloric Acid, one 50mg Sodium Nitrite Tablet and 100 Cuvettes.
2016-09-23
Advanced Instruments BR2 Total Bilirubin Test Kit, Reagents, and Cuvettes - For In Vitro Diagnostic Use. Advanced Instruments Total Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer for the determination of TOTAL (TBR) bilirubin in neonatal serum or plasma. Includes four 30mL bottles of Diluent, one 3mL bottle of 5mg/dL Bilirubin Equivalent, one bottle of 20mg/dL 3mL Bilirubin Equivalent, and 100 Cuvettes.
2016-09-23
Advanced Instruments BR2 Disposable Cuvettes - For In Vitro Diagnostic Use. Advanced Instruments Total Bilirubin Test Kit has been developed for use exclusively with the Advanced Instruments BR2 Bilirubin Stat-Analyzer Photometer. Contains one-hundred 4.5mL cuvettes.
2016-09-23
Advanced Instruments Palladox Disposable Satchet - The new single use Palladox disposable sachet is designed specifically to work with the Anoxomat System. The easy-to-use, single-use catalyst will simplify your anaerobic sample testing by minimizing catalyst handling time. The Palladox sachet reduces the oxygen in the jar in minutes and maintains an anaerobic environment for the duration of incubation. This product is the perfect solution to improve workflow efficiency, eliminate downtime and simplify anaerobic testing.
2020-09-21
Advanced Instruments Standard Anoxomat Jar, Large - Anoxomat Standard jars are available in a variety of sizes. The system capacity can be updated and expanded at any time — according to your laboratory’s needs.
2020-09-21
Advanced Instruments Standard Anoxomat Jar, Medium - Anoxomat standard jars are available in a variety of sizes. The system capacity can be updated and expanded at any time according to your laboratory's needs.
2020-09-21
Advanced Instruments Ergonomic Culture Jar, Large - The Advanced Instruments ergonomic anaerobic jars provide flexibility and ease of use for laboratory technicians while maximizing incubator and laboratory space. All Anoxomat jars are built to meet the highest microbiological and mechanical standards and minimize the risk of oxygen leaks. The large jar has a capacity of 24 petri dishes
2020-09-21
Advanced Instruments Ergonomic Culture Jar, Small - The Advanced Instruments ergonomic anaerobic jars provide flexibility and ease-of-use for laboratory technicians while maximizing incubator and laboratory space. All Anoxomat jars are built to meet the highest microbiological and mechanical standards and minimize the risk of oxygen leaks. The small jar has a capacity of 12 petri dishes.
2020-09-21
Advanced Instruments Anoxomat III Anaerobic Culture System (100V - 120V) - The Anoxomat system empowers customers to automatically and easily create exact, repeatable atmospheric environments. It is flexible and easy to use, keeping clinical and industrial microbiology labs productive and ready to culture a wide range of microbes.It is flexible and easy to use, keeping clinical and industrial microbiology labs productive and ready to culture a wide range of microbes.
2020-09-21
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 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® 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® 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® 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® 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 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 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® 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 Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene - Contains 960 1-200µL pipette tips
2016-09-23
Advanced Instruments GloCyte® High Level Control Vial (Single) - 3 mL vial of High Level Control
2016-09-23
Advanced Instruments GloCyte® Low Level Control Vial (Single) - 3 mL vial of Low Level Control
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.
2016-09-23
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.
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.
2019-03-22
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.
2016-09-23
Advanced Instruments Bin Setting Fluid – 10 mL - Bin-Setting Fluid (10 mL ampoule) for use with select Advanced Instruments' instruments
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.
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.
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
2020-09-21
Advanced Instruments 1500 mOsm Calibration Standard - 110 mL Bottle - Calibration standards are used to calibrate and/or check the performance of customer osmometers.
2020-09-21
Advanced Instruments 900 mOsm Calibration Standard - 110 mL Bottle - Calibration standards are used to calibrate and/or check the performance of customer osmometers.
2020-09-21
Advanced Instruments 500 mOsm Calibration Standard - 110 mL Bottle - Calibration standards are used to calibrate and/or check the performance of customer osmometers.
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.
2020-09-21