DEVICE: HER2 IQFISH pharmDx™ (05700572032465)

Device Identifier (DI) Information

HER2 IQFISH pharmDx™
K5731
In Commercial Distribution

Dako Denmark A/S
05700572032465
GS1

1
305047466 *Terms of Use
No description.
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Device Characteristics

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

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
Her2/neu/erbB2 mRNA expression IVD, kit, nucleic acid technique (NAT) A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of mRNA expression of the Her2/neu/erbB2 (v-erb-B2 avian erythroblastic leukaemia viral oncogene homolog 2) gene in a tumour tissue specimen, using a nucleic acid technique (NAT).
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FDA Product Code

[?]
Product Code Product Code Name
MVD System, Test, Her-2/Neu, Nucleic Acid Or Serum
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P040005 001
P040005 002
P040005 003
P040005 004
P040005 005
P040005 006
P040005 007
P040005 008
P040005 009
P040005 010
P040005 011
P040005 012
P040005 013
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Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: less than -18 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 20 Tests
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Device Record Status

22d4b094-db5e-45cf-8253-3c4dbb5f0846
July 06, 2018
3
September 15, 2014
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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