Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays 111010

GUDID 20816068020201

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.

ADVANCED INSTRUMENTS, INC.

Haematological cell analyser IVD, automated

• Primary Device ID: 20816068020201
• NIH Device Record Key: 112266c7-9dd2-4115-b843-b3600ff350d2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advanced Instruments GloCyte® Test Cartridge Kit - 8 Trays
• Version Model Number: 111010
• Catalog Number: 111010
• Company DUNS: 125006353
• Company Name: ADVANCED INSTRUMENTS, INC.
• Device Count: 200
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 40 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816068020207 [Unit of Use]
GS1	20816068020201 [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

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