BOND-PRIME AR0084

GUDID 05055331330505

BOND-PRIME Dewax Solution is a ready to use dewaxing solution intended for removal of paraffin wax from formalin-fixed, paraffin-embedded tissue, during immunohistochemistry (IHC) or in situ hybridization (ISH) procedures using the automated BOND-PRIME system.

LEICA BIOSYSTEMS NEWCASTLE LTD

Dewaxing solution IVD

• Primary Device ID: 05055331330505
• NIH Device Record Key: e4419408-08a2-4a2d-bc77-f09e3fe4e57b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOND-PRIME
• Version Model Number: AR0084
• Catalog Number: AR0084
• Company DUNS: 397134693
• Company Name: LEICA BIOSYSTEMS NEWCASTLE 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: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com
• Phone: +1(800)2480123
• Email: tech.support@leicabiosystems.com

Operating and Storage Conditions

• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius
• Storage Environment Temperature: Between 2 Degrees Celsius and 8 Degrees Celsius

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055331330505 [Primary]

FDA Product Code

• PPM: General Purpose Reagent

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: 2022-12-15
• Device Publish Date: 2022-12-07

On-Brand Devices [BOND-PRIME]

• 05055331331014: BOND-PRIME Polymer DAB Detection System is a biotin-free, polymeric horseradish peroxidase (HRP)
• 05055331330574: BOND-PRIME Polymer AP Detection Sytem is a biotin-free, polymeric alkaline phosphatase (AP)-link
• 05055331330550: BOND-PRIME Hematoxylin is a ready to use reagent that facilitates cell nuclei (blue) counterstai
• 05055331330536: BOND-PRIME Epitope Retrieval Solution 2 is a ready to use epitope retrieval solution intended fo
• 05055331330529: BOND-PRIME Epitope Retrieval Solution 1 is a ready to use epitope retrieval solution intended fo
• 05055331330512: BOND-PRIME Wash Solution Concentrate is a concentrated buffer solution, requiring initial diluti
• 05055331330505: BOND-PRIME Dewax Solution is a ready to use dewaxing solution intended for removal of paraffin w
• 05055331337504: For in vitro diagnostic use. ChromoPlex 1 Dual Detection is a biotin-free, polymeric horseradish