BioReady 80-1017

GUDID 00860010517611

BioReady, 40nm Gold PEG-COOH Gold Nanospheres

Nanocomposix, LLC

pH-adjusted buffer solution IVD

• Primary Device ID: 00860010517611
• NIH Device Record Key: 800ba5fd-d5bc-4001-99ef-48d711b50156
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BioReady
• Version Model Number: 40nm Gold PEG-COOH Gold Nanospheres
• Catalog Number: 80-1017
• Company DUNS: 159070825
• Company Name: Nanocomposix, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com
• Phone: 8585654227
• Email: info@nanocomposix.com

Operating and Storage Conditions

• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.
• Special Storage Condition, Specify: Between 0 and 0 *2-8C. Do Not Freeze.

Device Identifiers

Device Issuing Agency	Device ID
GS1	00860010517611 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-08-24
• Device Publish Date: 2023-08-16

On-Brand Devices [BioReady]

• 00860010517628: BioReady 40nm Gold Citrate Nanospheres
• 00860010517611: BioReady, 40nm Gold PEG-COOH Gold Nanospheres
• 00860010517604: BioReady, 150nm Carboxyl Gold Nanoshells