DEVICE: HercepTest™ for Automated Link Plarforms (05700572032007)

Device Identifier (DI) Information

HercepTest™ for Automated Link Plarforms
SK001
In Commercial Distribution

Dako Denmark A/S
05700572032007
GS1

1
305047466 *Terms of Use
HercepTest for Automated Link Platforms
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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
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

[?]
Product Code Product Code Name
MVC System, Test, Her-2/Neu, Ihc
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P980018 000
P980018 001
P980018 002
P980018 003
P980018 004
P980018 005
P980018 006
P980018 007
P980018 008
P980018 009
P980018 010
P980018 011
P980018 012
P980018 013
P980018 014
P980018 015
P980018 016
P980018 017
P980018 018
P980018 019
P980018 020
P980018 021
P980018 022
P980018 023
P980018 024
No CLOSE

Sterilization

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

[?]
Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius
Special Storage Condition, Specify: Fragile
Special Storage Condition, Specify: Store in the dark
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Clinically Relevant Size

[?]
Size Type Text
Device Size Text, specify: 50 Tests
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Device Record Status

fd9609a9-6c80-45d7-a1de-a9a842bffb1a
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

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

[?]
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

[?]
+4544859500
dako.dkregulatory@agilent.com
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