DEVICE: HER2 CISH pharmDx™ Kit (05700572032960)
Device Identifier (DI) Information
HER2 CISH pharmDx™ Kit
SK109
In Commercial Distribution
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
SK109
In Commercial Distribution
AGILENT TECHNOLOGIES SINGAPORE PTE LTD
HER2 CISH pharmDx Kit
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? |
---|---|---|---|---|
60255 | 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).
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NYQ | Chromogenic In Situ Hybridization, Nucleic Acid Amplification, Her2/Neu Gene, Breast Cancer |
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: Store in the dark |
Clinically Relevant Size
[?]Size Type Text |
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Device Size Text, specify: 20 Tests |
Device Record Status
23700536-ef99-466a-8e1c-73d88d501d4f
February 06, 2025
5
September 15, 2014
February 06, 2025
5
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