DEVICE: EGFR pharmDx™ for Autostainer (05700571103982)
Device Identifier (DI) Information
EGFR pharmDx™ for Autostainer
K1494
Not in Commercial Distribution
AGILENT TECHNOLOGIES, INC.
K1494
Not in Commercial Distribution
AGILENT TECHNOLOGIES, INC.
EGFR pharmDx for Autostainer
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
No | |
No | |
Yes | |
No | |
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? |
---|---|---|---|---|
57183 | 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NQF | Immunohistochemistry Assay, Antibody, Epidermal Growth Factor Receptor |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between 2 and 8 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 50 Tests |
Device Record Status
2c20064d-8dd6-41c1-a670-8c8707932acc
March 28, 2023
7
September 15, 2014
March 28, 2023
7
September 15, 2014
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
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
[?]
+1-805-566-6655
dako.usregulatory@agilent.com
dako.usregulatory@agilent.com