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 | |
|---|---|---|---|
| 00816068020023 | 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. | +1-781-894-0800 | info@novabio.com |
| 00816068020030 | 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. | +1-781-894-0800 | info@novabio.com |
| 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 |
| 00816068020658 | Advanced Instruments Swab Cleaners - Advanced Instruments swab cleaners are used to mitigate sample carry-over between tests | +1-781-894-0800 | info@novabio.com |
| 00816068020719 | Advanced Instruments 500 mOsm Calibration Standard - 110 mL Bottle - Calibration standards are used to calibrate and/or check the performance of customer osmometers. | +1-781-894-0800 | info@novabio.com |
| 00816068020726 | Advanced Instruments 900 mOsm Calibration Standard - 110 mL Bottle - Calibration standards are used to calibrate and/or check the performance of customer osmometers. | +1-781-894-0800 | info@novabio.com |
| 00816068020733 | Advanced Instruments 1500 mOsm Calibration Standard - 110 mL Bottle - Calibration standards are used to calibrate and/or check the performance of customer osmometers. | +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 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 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 Swab Cleaners - Advanced Instruments swab cleaners are used to mitigate sample carry-over between tests
2020-09-21
Advanced Instruments A2O System Fluid - A2O System Fluid is used for system cleaning during automated osmolality testing
2020-09-21
Advanced Instruments Cuvettes - Advanced Instruments cuvettes 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
Advanced Instruments 20 µL Pipet - Advanced Instruments pipettes are used to facilitate sample management while using Advanced Instruments osmometers
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 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 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 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 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 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 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 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 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 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 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 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 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