DEVICE: HercepTest™ (05700572031987)
Device Identifier (DI) Information
HercepTest™
K5204
In Commercial Distribution
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
K5204
In Commercial Distribution
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
HercepTest
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? |
---|---|---|---|---|
43270 | 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
MVC | System, Test, Her-2/Neu, Ihc |
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 |
Special Storage Condition, Specify: Fragile |
Clinically Relevant Size
[?]Size Type Text |
---|
Device Size Text, specify: 35 Tests |
Device Record Status
ee80735f-63bb-43ae-80e3-26827511459a
December 07, 2020
7
September 15, 2014
December 07, 2020
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
[?]
+4544859500
dako.dkregulatory@agilent.com
dako.dkregulatory@agilent.com