BOND™

Basic Information

• Brand Name: BOND™
• Primary DI: 05055331326003
• Version / Model: PA0304
• Catalog Number: PA0304
• Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD
• Labeler DUNS: 397134693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-04-02
• Public Version: 1
• Public Version Date: 2021-04-12
• Public Version Status: New
• Public Device Record Key: b7128176-77c7-443d-946f-a5c446485a79

Device Description

CD13 (38C12) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of human CD13 antigen in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).

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
56944	CD13 cell marker IVD, antibody	One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of CD13 cell marker in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055331326003	GS1

Customer Contacts

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

Storage Conditions

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