BOND-PRIME 091.1592

GUDID 09349458005436

The BOND-PRIME ARC Refresh Kit is a consumable kit for the BOND-PRIME staining platform. The kit contains two items that must be periodically replaced to maintain staining quality: a set of BOND-PRIME Covertiles and a BOND-PRIME Mixing Well Plate.

LEICA BIOSYSTEMS MELBOURNE PTY LTD

Microscope slide stainer IVD

• Primary Device ID: 09349458005436
• NIH Device Record Key: 46db7df8-1849-4599-b4a2-a9b5140bcf23
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOND-PRIME
• Version Model Number: BOND-PRIME ARC REFRESH KIT
• Catalog Number: 091.1592
• 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: true
• Serial Number: false
• 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	09349458005436 [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: 2021-11-22
• Device Publish Date: 2021-11-12

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.