BOND-III processing module 21.2201

GUDID 09349458000004

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: 09349458000004
• NIH Device Record Key: be3fef92-fa96-4c83-9610-e0fae9563e58
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOND-III processing module
• Version Model Number: BOND-III
• Catalog Number: 21.2201
• 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	09349458000004 [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: 2022-07-26
• Device Publish Date: 2022-07-18

Devices Manufactured by LEICA BIOSYSTEMS MELBOURNE PTY LTD

• 09349458005665 - BOND-PRIME automated stainer: 2024-10-28 The BOND system is designed for immunostaining histological specimens mounted on microscope slides.
• 09349458005634 - BOND: 2024-08-12 Used with the slide labeller to print stick on labels to attach to slides. The slides are used on the BOND instrument.
• 09349458005641 - BOND: 2024-08-12 Used with the slide labeller to print stick on labels to attach to slides. The slides are used on the BOND instrument.
• 09349458005658 - BOND: 2024-08-12 Used to print stick-on labels to attach to slides. The labelled slides are used on the BOND instrument.
• 09349458005627 - BOND: 2024-04-15
• 09349458005573 - HistoCore PELORIS: 2023-09-07 HistoCore PELORIS 3 Win10/I-Scan Upgrade Kit
• 09349458005580 - HistoCore PELORIS: 2023-09-07 HistoCore PELORIS 3 Win10 Upgrade Kit
• 09349458002657 - BOND: 2022-07-28 Used to print stick-on labels to attach to slides. The labelled slides are used on the BOND instrument.