DEVICE: BOND ORACLE HER2 IHC System (05055331301291)

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Device Identifier (DI) Information

BOND ORACLE HER2 IHC System
TA9145
TA9145
LEICA BIOSYSTEMS NEWCASTLE LTD
05055331301291
GS1
1
Bond Oracle HER2 IHC System is a semi quantitative immunohistochemical assay to determine HER2 oncoprotein status in breast cancer in breast tissue processed for histological evaluation.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
No
Yes
Yes
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
C-erbB2/Her2/neu oncoprotein IVD, kit, enzyme immunohistochemistry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of c-erbB2 oncoprotein, also known as Her2 or neu oncoprotein, in a clinical specimen using an enzyme immunohistochemistry method.
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FDA Product Code

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Product Code Product Code Name
MVC System, Test, Her-2/Neu, Ihc
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
September 23, 2014

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

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+1 800 248 0123
tech.support@Leicabiosystems.com
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