DEVICE: BOND™ (05055331328700)
Device Identifier (DI) Information
BOND™
PA0831
In Commercial Distribution
PA0831
LEICA BIOSYSTEMS NEWCASTLE LTD
PA0831
In Commercial Distribution
PA0831
LEICA BIOSYSTEMS NEWCASTLE LTD
Anaplastic Lymphoma Kinase (5A4) monoclonal antibody is intended to be used for the qualitative identification by light microscopy of endogenous ALK and ALK fusion proteins in formalin-fixed, paraffin-embedded tissue by immunohistochemical staining using the automated BOND system (includes Leica BOND-MAX system and Leica BOND-III system).
Device Characteristics
Labeling does not contain MRI Safety Information | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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56791 | Anaplastic lymphoma kinase IVD, antibody |
One or multiple immunoglobulins capable of binding to specific antigenic determinants and intended to be used for the qualitative and/or quantitative detection of anaplastic lymphoma kinase, also known as ALK protein, CD246 or p80, in a clinical specimen.
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Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
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NJT | Immunohistochemistry Reagents And Kits |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
2e9115ed-3571-447e-8f3a-fb0ae2fc06fc
May 03, 2021
1
April 23, 2021
May 03, 2021
1
April 23, 2021
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(800)2480123
tech.support@leicabiosystems.com
tech.support@leicabiosystems.com