BOND ORACLE HER2 IHC System TA9145

GUDID 05055331301291

Bond Oracle HER2 IHC System is a semi quantitative immunohistochemical assay to determine HER2 oncoprotein status in breast cancer in breast tissue pr

LEICA BIOSYSTEMS NEWCASTLE LTD

C-erbB2/Her2/neu oncoprotein IVD, kit, enzyme immunohistochemistry

• Primary Device ID: 05055331301291
• NIH Device Record Key: a7475889-95a1-4916-a866-cf51a7ff5642
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BOND ORACLE HER2 IHC System
• Version Model Number: TA9145
• Catalog Number: TA9145
• Company DUNS: 397134693
• Company Name: LEICA BIOSYSTEMS NEWCASTLE LTD
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: true
• Device Combination Product: true
• 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: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1 800 248 0123
• Email: tech.support@Leicabiosystems.c

Operating and Storage Conditions

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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05055331301291 [Primary]

FDA Product Code

• MVC: System, Test, Her-2/Neu, Ihc

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2014-09-23

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