BioReady

Basic Information

• Brand Name: BioReady
• Primary DI: 00860010517628
• Version / Model: 40nm Gold Citrate Nanospheres
• Catalog Number: 80-1018
• Company Name: Nanocomposix, LLC
• Labeler DUNS: 159070825
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2023-08-16
• Public Version: 1
• Public Version Date: 2023-08-24
• Public Version Status: New
• Public Device Record Key: 0775c107-53de-415f-8832-edbd6c7c9f65

Device Description

BioReady 40nm Gold Citrate Nanospheres

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57916	Citrate staining/testing reagent IVD	A citrate solution (citric acid solution) intended to be used alone or in combination with other IVDs in the processing, staining, and/or testing of clinical laboratory specimens.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00860010517628	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Storage Conditions

• Type: Special Storage Condition, Specify
• Special Conditions: 2-8C. Do Not Freeze.