Home GUDID 00816068020139
Advanced Instruments GloCyte® Automated Cell Counter System
Primary DI 00816068020139
Brand Advanced Instruments GloCyte® Automated Cell Counter System
Company Advanced Instruments, LLC
Model GloCyte
Catalog number GloCyte
Device description 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.
Published 2016-09-23
Public version status Update
Distribution status In Commercial Distribution
MRI safety Labeling does not contain MRI Safety Information
Rx true
Product Codes# Code, Name table Code Name GKL Counter, Cell, Automated (Particle Counter)
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class GKL Counter, Cell, Automated (Particle Counter) Hematology 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status 00816068020139 Primary GS1 0
Alternate GTIN / UPC / EAN Codes Source identifier, GTIN-14 normalized, UPC-A table Source identifier GTIN-14 normalized UPC-A EAN-13 00816068020139 00816068020139 816068020139 0816068020139
GMDN Terms# Term, Definition table Term Definition Haematological cell analyser IVD, automated An electrically-powered laboratory instrument intended to be used for the enumeration of a haematological cell population, using technology which may include cell lysis, electrical impedance, conductivity and/or light scatter to measure and/or calculate white cell, red cell and platelet parameters and indices in a clinical specimen. The device operates with minimal technician involvement and complete automation of all procedural steps.
Regulatory Flags# DUNS number 125006353 Device count 1 Kit true Other Devices From This Company# Primary DI, Brand, Model table Primary DI Brand Model Catalog Published 10816068020174 Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene 800097 800097 2016-09-23 10816068020211 Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit 111011 111011 2016-09-23 00816068020535 Advanced Instruments RBC Reagent Filtration Kit 111014 111014 2021-05-21 00816068020856 Advanced Instruments GloCyte RBC & TNC Verification & Linearity Kit 111280 111280 2020-07-21 20816068020201 Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays 111010 111010 2016-09-23 00816068020009 Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume 806054 806054 2016-09-23 00816068020016 Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume 806053 806053 2016-09-23 00816068020153 Advanced Instruments GloCyte® Vacuum Preparation Station Assembly 111076 111076 2016-09-23 00816068020238 Advanced Instruments GloCyte® Controls Kit 111013 111013 2016-09-23 00816068020245 Advanced Instruments GloCyte® Count Template Cartridge 111153 111153 2016-09-23 10816068020266 Advanced Instruments Clinitrol 290 Reference Solution, 5mL Ampule, Pkg 10 3LA029 3LA029 2020-09-21 10816068020303 Advanced Instruments Calibration Standard 2000 mOsm - 2mL Ampule - Pkg 10 3MA200 3MA200 2020-09-21 10816068020310 Advanced Instruments 50 mOsm Calibration Standard - 2mL Ampule - Pkg 10 3MA005 3MA005 2020-09-21 10816068020365 Advanced Instruments Clinitrol 290 Reference Solution - 2mL Ampule - Pkg 10 3MA029 3MA029 2020-09-21 10816068020372 Advanced Instruments 850 mOsm Calibration Standard - 2mL Ampule - Pkg 10 3MA085 3MA085 2020-09-21 10816068020433 Advanced Instruments 100 mOsm Calibration Standard - 5mL Ampule - Pkg 10 3LA011 3LA011 2020-09-21 10816068020440 Advanced Instruments 1500 mOsm Calibration Standard - 5mL Ampule - Pkg 10 3LA151 3LA151 2020-09-21 10816068020457 Advanced Instruments 500 mOsm Calibration Standard - 5mL Ampule - Pkg 10 3LA051 3LA051 2020-09-21 10816068020464 Advanced Instruments 900 mOsm Calibration Standard - 5mL Ampule - Pkg 10 3LA091 3LA091 2020-09-21 10816068020471 Advanced Instruments 2000 mOsm Calibration Standard - 5mL Ampule - Pkg 10 3LA201 3LA201 2020-09-21
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00816068020535 Advanced Instruments RBC Reagent Filtration Kit Advanced Instruments, LLC GKL 2021-05-21 00858604006108 IVOS HAMILTON THORNE, INC. GKL 2019-11-30 00858604006719 CEROS HAMILTON THORNE, INC. GKL 2019-11-30 00630414222882 ADVIA® 120/2120/2120i CBC TIMEpac Siemens Healthcare Diagnostics Inc. GKL 2016-09-24 00630414222899 ADVIA 120/2120/2120i® DIFF TIMEpac Siemens Healthcare Diagnostics Inc. GKL 2016-09-24 00630414222905 ADVIA 120/2120/2120i® autoRETIC Siemens Healthcare Diagnostics Inc. GKL 2016-09-24 00630414222912 ADVIA 120/2120/2120i® AUTOretic Siemens Healthcare Diagnostics Inc. GKL 2016-09-24 00630414222929 ADVIA 120/2120/2120i® Sheath/Rinse Siemens Healthcare Diagnostics Inc. GKL 2016-09-24 00630414222943 ADVIA 120/2120/2120i® Defoamer Siemens Healthcare Diagnostics Inc. GKL 2016-09-24 00630414222950 ADVIA 120/2120/2120i® CN-FREE CBC TIMEPAC Siemens Healthcare Diagnostics Inc. GKL 2016-09-24 00630414223032 ADVIA 120/2120/2120i® Sheath/Rinse Siemens Healthcare Diagnostics Inc. GKL 2016-09-24 00630414224305 ADVIA 120/2120/2120i® OPTIpoint Siemens Healthcare Diagnostics Inc. GKL 2016-09-24 00630414224329 ADVIA 120/2120/2120i® OPTIpoint Siemens Healthcare Diagnostics Inc. GKL 2016-09-24 00630414473383 ADVIA 120/2120/2120i® Perox Sheath Siemens Healthcare Diagnostics Inc. GKL 2016-09-24 10816068020174 Advanced Instruments Glocyte® Tips, 10 Pks of 96, 1-200uL Polypropylene Advanced Instruments, LLC GKL 2016-09-23 10816068020211 Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit Advanced Instruments, LLC GKL 2016-09-23 10816068020228 Advanced Instruments GloCyte® Total Nucleated Cell Test Reagent Kit Advanced Instruments, LLC GKL 2016-09-23 10816068020204 Advanced Instruments GloCyte® Test Cartridge & Tray - 25 Cartridges Advanced Instruments, LLC GKL 2016-09-23 15099590233754 COULTER Latron CP-X Beckman Coulter, Inc. GKL 2016-09-23 15099590250683 COULTER Latron Beckman Coulter, Inc. GKL 2016-09-23 15099590250690 COULTER Latron Beckman Coulter, Inc. GKL 2016-09-23 20816068020201 Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays Advanced Instruments, LLC GKL 2016-09-23 00816068020009 Advanced Instruments GloCyte® Pipette, 30µL Fixed Volume Advanced Instruments, LLC GKL 2016-09-23 00816068020016 Advanced Instruments GloCyte® Pipette, 10µL Fixed Volume Advanced Instruments, LLC GKL 2016-09-23 00816068020146 Advanced Instruments GloCyte® Instrument Assembly Advanced Instruments, LLC GKL 2016-09-23 00816068020153 Advanced Instruments GloCyte® Vacuum Preparation Station Assembly Advanced Instruments, LLC GKL 2016-09-23 00816068020245 Advanced Instruments GloCyte® Count Template Cartridge Advanced Instruments, LLC GKL 2016-09-23 10837461002475 iQ®200 BECKMAN COULTER IRELAND INC. GKL 2016-09-07 04987562402021 Automated Hematology Analyzer pocH-100i SYSMEX CORPORATION GKL 2016-08-04 04987562429219 Automated Hematology Analyzer XP series XP-300 SYSMEX CORPORATION GKL 2016-08-04