BOND

Basic Information

• Brand Name: BOND
• Primary DI: 05055331337405
• Version / Model: DS9202-U
• Catalog Number: DS9202-U
• Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD
• Labeler DUNS: 397134693
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-11
• Public Version: 1
• Public Version Date: 2025-12-19
• Public Version Status: New
• Public Device Record Key: 5cb6f68d-ea8e-4029-a891-fd8f4ccc4032

Device Description

This reagent is a General Purpose Reagent. For Laboratory Use. The BOND-PRIME RNAscope® Brown Detection System enables the user to perform chromogenic in situ hybridization (CISH) on the automated Leica BOND-PRIME system. It is intended for use with nucleic acid probes on formalin-fixed, paraffin-embedded (FFPE) tissue.

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
PPM	General Purpose Reagent	Pathology	864.4010	1

GMDN Terms

Code	Name	Definition	Implantable	Status
55768	Propoxyphene IVD, control	A material which is used to verify the performance of an assay intended to be used for the qualitative and/or quantitative detection of propoxyphene in a clinical specimen.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05055331337405	GS1

Customer Contacts

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

Storage Conditions

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