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Advanced Instruments, LLC

Matched from indexed company URL: Advanced Instruments, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
12170581217058Advanced Instruments, LLC1N2026-01-012 Technology Way NORWOOD MA US 02062
12210201221020Advanced Instruments, LLC1N2026-01-0125 BRADLEY DR. WESTBROOK ME US 04092

GUDID Contact Samples#

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

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00816068020009Advanced 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.+1-781-894-0800info@novabio.com
00816068020016Advanced 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.+1-781-894-0800info@novabio.com
00816068020153Advanced 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.+1-781-894-0800info@novabio.com
00816068020238Advanced 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.+1-781-894-0800info@novabio.com
00816068020245Advanced 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.+1-781-894-0800info@novabio.com
00816068020535Advanced 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+1-781-894-0800info@novabio.com
00816068020856Advanced 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.+1-781-894-0800info@novabio.com
20816068020201Advanced 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.+1-781-894-0800info@novabio.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
299421663348799K790608BL BILIRUBINOMETERCIG1979-06-15
299421571762573K152776Glocyte Automated Cell Counter SystemGKL2016-05-27
299421171503784
299421184180033
299421186846897
299421558992027
299421596665306
3220181683147123

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GKL12016-05-27
CIG11979-06-15

PMN#

GUDID#

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.

Advanced Instruments, LLC

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.

Advanced Instruments, LLC

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.

Advanced Instruments, LLC

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.

Advanced Instruments, LLC

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.

Advanced Instruments, LLC

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.

Advanced Instruments, LLC

2020-09-21

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