ThermoBrite Elite Instrument 3800-007000-001

GUDID 09349458005443

ThermoBrite Elite automates protocols for FISH testing of pathology specimens mounted on microscope slides. ThermoBrite Elite fully automates pre and post hybridization steps while providing temperature control for on-board denaturation and hybridization. Microscope slides subsequently undergo interpretation by a qualified healthcare professional to aid diagnosis.

LEICA BIOSYSTEMS MELBOURNE PTY LTD

Microscope slide hybridization/denaturation incubator IVD

• Primary Device ID: 09349458005443
• NIH Device Record Key: b80cfa7e-7702-4957-a27e-360e0c6cfb4d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ThermoBrite Elite Instrument
• Version Model Number: 3800-007000-001
• Catalog Number: 3800-007000-001
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349458005443 [Primary]

FDA Product Code

• JRG: Block, Heating

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

• 09349458005672 - BOND-III Processing Module: 2025-07-08 The BOND system automates clinical protocols for immunostaining of pathology specimens mounted on microscope slides. Microscope
• 09349458005689 - BOND-MAX Processing Module: 2025-07-08 The BOND system automates clinical protocols for immunostaining of pathology specimens mounted on microscope slides. Microscope
• 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