BOND-MAX Processing Module RS49.0051

GUDID 09349458005689

The BOND system automates clinical protocols for immunostaining of pathology specimens mounted on microscope slides. Microscope slides subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis.

LEICA BIOSYSTEMS MELBOURNE PTY LTD

Microscope slide stainer IVD

• Primary Device ID: 09349458005689
• NIH Device Record Key: a88e5a25-4309-4fe6-9140-5cbacd7f3203
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOND-MAX Processing Module
• Version Model Number: BOND-MAX
• Catalog Number: RS49.0051
• Company DUNS: 753184944
• Company Name: LEICA BIOSYSTEMS MELBOURNE PTY LTD
• 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: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349458005689 [Primary]

FDA Product Code

• KPA: Slide Stainer, Automated

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: 2025-07-08
• Device Publish Date: 2025-06-30

On-Brand Devices [BOND-MAX Processing Module]

• 09349458000011: The BOND system automates clinical protocols for immunostaining of pathology specimens mounted o
• 09349458005689: The BOND system automates clinical protocols for immunostaining of pathology specimens mounted o