BOND 49.0644

GUDID 09349458005504

The BOND System Control Kit provides the computer which contains the software (version 7.0) that controls the Processing Modules(s), as well as the Slide Labeler, Handheld barcode scanner, ethernet switch and power cable.

LEICA BIOSYSTEMS MELBOURNE PTY LTD

Microscope slide stainer IVD

• Primary Device ID: 09349458005504
• NIH Device Record Key: cd172ba2-d753-49fc-98bc-6d33eac5f6a3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOND
• Version Model Number: BOND System Control Kit (version 7)
• Catalog Number: 49.0644
• 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	09349458005504 [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