Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit 111011

GUDID 10816068020211

For In Vitro Diagnostic Use. Advanced Instruments GloCyte® Red Blood Cell Reagent Kit has been developed for use exclusively with the Advanced Instruments GloCyte® Automated Cell Counter System. Contains three 1.8mL vials of Red Blood Cell (RBC) Reagent.

Advanced Instruments, LLC

Red cell antibody eluting IVD, reagent

• Primary Device ID: 10816068020211
• NIH Device Record Key: 6a273521-b0c5-4492-96ca-f30f451f1419
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Advanced Instruments GloCyte® Red Blood Cell Test Reagent Kit
• Version Model Number: 111011
• Catalog Number: 111011
• Company DUNS: 125006353
• Company Name: Advanced Instruments, LLC
• Device Count: 3
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: true
• Device Kit: true
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	00816068020214 [Unit of Use]
GS1	10816068020211 [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: 2026-02-06
• Device Publish Date: 2016-09-23

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