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 Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD Microscope slide stainer IVD 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

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• 09349458004811 - HistoCore PELORIS: 2022-07-28 The HistoCore PELORIS 3 dual retort rapid tissue processor automates preparation of tissue samples for sectioning. This is achie
• 09349458000004 - BOND-III processing module: 2022-07-26 The BOND system automates clinical protocols for immunostaining of pathology specimens mounted on microscope slides. Microscope
• 09349458000011 - BOND-MAX Processing Module: 2022-07-26 The BOND system automates clinical protocols for immunostaining of pathology specimens mounted on microscope slides. Microscope
• 09349458001261 - BOND: 2022-07-26 BOND Mixing Station contains six cavities that are used to mix shortlife reagents that must be mixed just before use. The mixing