Advanced Instruments GloCyte® Instrument Assembly 111000

GUDID 00816068020146

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.

ADVANCED INSTRUMENTS, INC.

Haematological cell analyser IVD, automated

• Primary Device ID: 00816068020146
• NIH Device Record Key: a4c78448-4eb9-4543-a463-862e60665c4f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advanced Instruments GloCyte® Instrument Assembly
• Version Model Number: 111000
• Catalog Number: 111000
• Company DUNS: 125006353
• Company Name: ADVANCED INSTRUMENTS, INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com
• Phone: +17813209000
• Email: Orders@aicompanies.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816068020146 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152776

FDA Product Code

• GKL: Counter, Cell, Automated (Particle Counter)

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-12-23
• Device Publish Date: 2016-09-23

Devices Manufactured by ADVANCED INSTRUMENTS, INC.

• 00816068020535 - Advanced Instruments RBC Reagent Filtration Kit: 2021-05-31 The RBC Reagent Filtration Kit is used for filtering the RBC Reagent when diluent and reagent counts exceed the acceptance crite
• 00816068020290 - Advanced Instruments Renol 2 Level Urine Osmolality Control - 3mL Vial - Pkg 8: 2020-09-29 Renol urine osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls may be used
• 00816068020351 - Advanced Instruments Protinol 3 Level Control - 3mL Vial - Pkg 9: 2020-09-29 Protinol protein-based osmolality controls are intended for use in evaluating the performance of customer osmometers. Controls m
• 00816068020481 - Advanced Instruments Osmolality Linearity Set - 5 Level - 5mL Ampule - Pkg 10: 2020-09-29 The Osmolality Linearity Set is designed to help clinical laboratories easily monitor osmometer performance specifications and f
• 00816068020504 - Advanced Instruments Ease-Eject 20-Microliter Sampler: 2020-09-29 Advanced Instruments Ease-Eject 20-Microliter Sampler for use with Advanced Instruments Osmo1® Single-Sample Micro-Osmometer or
• 00816068020542 - Advanced Instruments Osmo1® Single-Sample Micro-Osmometer: 2020-09-29 With the Osmo1 Single-Sample Micro-Osmometer, we’ve bundled together accurate and reliable osmolality measurement with ease-of
• 00816068020559 - Advanced Instruments OsmoPRO Multi-Sample Micro-Osmometer: 2020-09-29 Supporting efficient workflows for mid- to high-volume clinical chemistry labs, the OsmoPRO features a convenient carousel desig
• 00816068020566 - Advanced Instruments 30 µL Pipet: 2020-09-29 Advanced Instruments pipettes are used to facilitate sample management while using Advanced Instruments osmometers