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 |
| 00816068020900 | 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. | +1-781-894-0800 | info@novabio.com |
| 00816068020917 | 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. | +1-781-894-0800 | info@novabio.com |
| 00816068020924 | 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 | +1-781-894-0800 | info@novabio.com |
| 00816068020948 | 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. | +1-781-894-0800 | info@novabio.com |
| 00816068020955 | 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. | +1-781-894-0800 | info@novabio.com |
| 00816068020962 | 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. | +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 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 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 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 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 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 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 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 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 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 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 Sample Diluent - 30mL bottle of Diluent
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 5mg/dL Bilirubin Equivalent Solution - 3mL bottle of 5 mg/dL Bilirubin Equivalent Solution
2016-09-23
Advanced Instruments BR2 Sodium Nitrite - 50mg Sodium Nitrite Tablet
2016-09-23
Advanced Instruments BR2 Sulfanilic Acid - 25mL bottle of Sulfanilic Acid
2016-09-23
Advanced Instruments BR2 Hydrochloric Acid - 25mL bottle of Hydrochloric Acid
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® 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