BOND-PRIME DS9397

GUDID 05055331337504

For in vitro diagnostic use. ChromoPlex 1 Dual Detection is a biotin-free, polymeric horseradish peroxidase (HRP)-linker and polymeric alkaline phosphatase (AP)-linker antibody conjugate system for the visualization of tissue-bound mouse IgG and rabbit primary antibodies. It is intended for target visualization by immunohistochemistry (IHC) in sections of formalin fixed, paraffin-embedded tissue using the automated BOND-PRIME system. The clinical interpretation of any staining or its absence should be complemented by morphological studies and proper controls should be evaluated within the context of the patient’s clinical history and other diagnostic tests by a qualified pathologist. ChromoPlex 1 Dual Detection for BOND-PRIME is intended to be used with other devices for visualization of staining and as such, qualitative or semi-quantitative diagnostic function including specific disease indication and intended use population is described within the associated device labelling as required for that device.

LEICA BIOSYSTEMS NEWCASTLE LTD

Immunohistochemistry antibody detection IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 05055331337504
• NIH Device Record Key: 33f1977c-f077-407b-9efd-7674b56862ab
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOND-PRIME
• Version Model Number: DS9397
• Catalog Number: DS9397
• 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
• 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
• 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
• 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
• 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
• 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
• 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	05055331337504 [Primary]

FDA Product Code

• NJT: Immunohistochemistry Reagents And Kits

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: 2024-06-19
• Device Publish Date: 2024-06-11

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