BOND S21.4605

GUDID 09349458005290

Used to print stick-on labels to attach to slides. The labelled slides are used on the BOND instrument.

LEICA BIOSYSTEMS MELBOURNE PTY LTD

Microscope slide stainer IVD

• Primary Device ID: 09349458005290
• NIH Device Record Key: 79f628c0-2513-47bc-a380-caa0e059a6eb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOND
• Version Model Number: BOND Cognitive Slide Labeller
• Catalog Number: S21.4605
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	09349458005290 [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

On-Brand Devices [BOND]

• 09349458004859: The BOND Controller provides the computer that contains the software (version 6.0/W10 IoT) that
• 09349458005535: The BOND-ADVANCE Controller provides the computer that contains the software (version 7.0) that
• 09349458005528: The BOND- ADVANCE Terminal provides the computer that contains the software (version 7.0) that c
• 09349458005511: BOND Controller (7.0)
• 09349458005504: The BOND System Control Kit provides the computer which contains the software (version 7.0) that
• 09349458005481: Used for reagent identification and can also be used to identify slides when labels printed on s
• 09349458005474: The BOND-ADVANCE Controller provides the computer that contains the software (version 6.0) that
• 09349458005467: The BOND- ADVANCE Terminal provides the computer that contains the software (version 6.0/W10 IoT
• 09349458005450: The BOND System Control Kit provides the computer which contains the software (version 6.0/W10 I
• 09349458005290: Used to print stick-on labels to attach to slides. The labelled slides are used on the BOND inst
• 09349458005283: Used with the slide labeller to print stick on labels to attach to slides. The slides are used o
• 09349458005269: Used with the slide labeller to print stick on labels to attach to slides. The slides are used o
• 09349458005009: Transparent plastic covers that sit over slides during staining, provided in a pack of 100.
• 09349458002640: Transparent plastic covers that sit over slides during staining, provided in a pack of 160.
• 09349458002633: Used with the slide labeller to print stick on labels to attach to slides. The slides are used o
• 09349458001261: BOND Mixing Station contains six cavities that are used to mix shortlife reagents that must be m
• 09349458002657: Used to print stick-on labels to attach to slides. The labelled slides are used on the BOND inst
• 09349458005627: Zebra ZD421 Label Printer Spare
• 09349458005658: Used to print stick-on labels to attach to slides. The labelled slides are used on the BOND inst
• 09349458005641: Used with the slide labeller to print stick on labels to attach to slides. The slides are used o
• 09349458005634: Used with the slide labeller to print stick on labels to attach to slides. The slides are used o