DEVICE: Dako (05700571104057)
Device Identifier (DI) Information
Dako
K1907
Not in Commercial Distribution
AGILENT TECHNOLOGIES, INC.
K1907
Not in Commercial Distribution
AGILENT TECHNOLOGIES, INC.
c-Kit 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? |
---|---|---|---|---|
57033 | CD117 (c-kit) cell marker IVD, kit, enzyme immunohistochemistry |
A collection of reagents and other associated materials intended to be used for the qualitative and/or quantitative detection of CD117 (c-kit) cell marker in a clinical specimen, using an enzyme immunohistochemistry method.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
NKF | Immunohistochemistry Antibody Assay, C-Kit |
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: 35 Tests |
Device Record Status
b3085337-af37-4adc-95ce-74ce743d79e7
December 07, 2020
5
October 21, 2016
December 07, 2020
5
October 21, 2016
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