BOND

Basic Information

• Brand Name: BOND
• Primary DI: 05055331317599
• Version / Model: DS9390
• Catalog Number: DS9390
• Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD
• Labeler DUNS: 397134693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-07
• Public Version: 1
• Public Version Date: 2022-12-15
• Public Version Status: New
• Public Device Record Key: 5a0cc35f-ca51-4243-84af-dc269753713f

Device Description

BOND Polymer Refine Red Detection is a biotin-free, polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the visualization of tissue-bound mouse IgG, mouse IgM and rabbit primary antibodies.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: No
• 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
NJT	Immunohistochemistry Reagents And Kits	Hematology	864.1860	1

GMDN Terms

Code	Name	Definition	Implantable	Status
57768	Immunohistochemistry antibody detection IVD, reagent	A substance or reactant intended to be used together with a parent IVD to perform a specific function in an immunohistochemistry assay that is used for the qualitative and/or quantitative detection of primary antibodies directed at specific cellular markers in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055331317599	GS1

Customer Contacts

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

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 2 – 8 Degrees Celsius