DEVICE: EGFR pharmDx™ for Autostainer (05700571103982)

Device Identifier (DI) Information

EGFR pharmDx™ for Autostainer
K1494
In Commercial Distribution

Dako North America, Inc.
05700571103982
GS1

1
099999732 *Terms of Use
EGFR pharmDx for Autostainer
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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
Epidermal growth factor receptor (EGFR) IVD, kit, enzyme immunohistochemistry A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of epidermal growth factor receptor (EGFR) in a clinical specimen, using an enzyme immunohistochemistry method.
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FDA Product Code

[?]
Product Code Product Code Name
NQF Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
P030044 000
P030044 001
P030044 002
P030044 003
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
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Clinically Relevant Size

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

2c20064d-8dd6-41c1-a670-8c8707932acc
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

[?]
+1-805-566-6655
dako.usregulatory@agilent.com
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